Total 20 job vacancies by No Deviation Pte. Ltd.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

Position Overview

We are looking for an Upstream Biotech personnel to support upstream biologics manufacturing activities in a GMP environment. The role will focus on cell culture operations, seed train expansion, bioreactor operations, media preparation, process monitoring, sampling, batch record execution, and GMP documentation.

The candidate should have hands-on experience in upstream biologics or biopharmaceutical manufacturing and be comfortable working in a GMP cleanroom environment.

Key Responsibilities

• Support daily upstream biologics manufacturing operations, including cell culture, seed train, inoculation, bioreactor operation, harvest, and related activities.
• Perform media preparation, filtration, transfer, and material handling in accordance with approved procedures.
• Operate upstream process equipment such as bioreactors, single-use systems, mixers, pumps, filters, and harvest equipment.
• Monitor process parameters such as pH, dissolved oxygen, temperature, agitation, gas flow, viable cell density, viability, osmolality, and metabolites.
• Perform in-process sampling and coordinate with QC for testing requirements.
• Execute production steps according to approved batch records, SOPs, GMP, and safety requirements.
• Complete GMP documentation accurately, including batch records, logbooks, equipment records, and cleaning records.
• Support basic troubleshooting of process or equipment issues during manufacturing operations.
• Support deviation reporting, investigation inputs, CAPA, and change control activities where required.
• Maintain manufacturing areas in a state of GMP readiness, including housekeeping, equipment status checks, material reconciliation, and cleanroom discipline.
• Work closely with Manufacturing, MSAT, QA, QC, Engineering, Automation, and Validation teams to ensure smooth production execution.
• Support facility start-up, process transfer, engineering runs, PPQ, or validation activities where required.

Required Qualifications

• Diploma / Degree in Biotechnology, Life Sciences, Bioprocess, Pharmaceutical Science, Chemical Process Technology, or related discipline.
• Minimum 1–5 years of relevant experience in upstream biologics manufacturing, cell culture, or biopharmaceutical production.
• Good understanding of GMP, GDP, aseptic practices, contamination control, and cleanroom behaviour.
• Experience with single-use bioreactors, wave bags, stainless-steel bioreactors, filtration systems, pumps, and automated manufacturing systems will be advantageous.
• Familiarity with DeltaV, MES, SCADA, electronic batch records, or LIMS will be an added advantage.
• Able to work independently and as part of a shift or manufacturing team.
• Willing to work in a GMP cleanroom environment and follow strict gowning requirements.
• Strong attention to detail and good documentation discipline

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

As a Process Technician, you will support plant operations by assisting with troubleshooting, process optimization, and monitoring processing parameters. Your duties include preparing solutions, staging components for autoclaving, and aiding in production sample testing. You will ensure compliance with GMP, EHS standards, and regulatory requirements, follow procedures, evaluate documentation, and contribute to safety audits while working with internal and external inspectors.

Key Responsibilities

• Play a key role in the hands-on execution of plant operations while providing valuable support to Manufacturing Associates in troubleshooting and resolving issues.
• Monitor and analyze processing parameters to identify trends and uncover opportunities for process optimization and improvement.
• Prepare solutions and equipment, ensuring smooth operation and efficiency.
• Stage components for autoclaving and washing, contributing to the production flow.
• Assist in the testing of production samples and leverage any experience with analytical instruments to enhance process accuracy.
• Actively participate in continuous improvement initiatives, helping to drive operational excellence.
• Contribute to safety audits and ensure that all activities align with industry standards and regulations.
• Ensure strict adherence to EHS, regulatory, and GMP requirements, maintaining a high level of compliance.
• Follow written procedures, quickly recognize malfunctions, and take prompt action to report and resolve issues.
• Evaluate documentation and data in line with company and regulatory guidelines, ensuring accuracy and compliance.
• Engage with internal and external inspectors, maintaining open communication and fostering transparency.
• Apply your knowledge of GMP to ensure the highest standards of production practices.
• Use basic statistical and mathematical skills to analyze data and make informed decisions.
• Effectively organize tasks, manage multiple priorities, and meet deadlines in a fast-paced environment.
• Leverage your understanding of basic chemistry, biology, and physical principles to support various plant operations.
• Have a solid grasp of analytical methods to ensure precision and quality in production.

Required Qualifications

• Diploma in Science or Engineering.
• NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences, or Bio-processing-related disciplines.
• Fresh graduates are highly encouraged to apply.
• Proficiency in reading and writing English.
• Strong commitment to cGMP and EHS compliance in clean-room plant operations (prior experience with cGMP is a plus).
• Knowledge of plant and unit operations (e.g., autoclaves, parts washers, process equipment) and strong problem-solving skills.
• Excellent self-motivated team player with a hands-on attitude and effective communication skills.
• Familiarity with systems like Emerson DeltaV, LIMS, and TrackWise.
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles.
• Willingness to work shifts, including 24/7 operations.
• Strong mechanical ability and expertise.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

As a Process Technician, you will support plant operations by assisting with troubleshooting, process optimization, and monitoring processing parameters. Your duties include preparing solutions, staging components for autoclaving, and aiding in production sample testing. You will ensure compliance with GMP, EHS standards, and regulatory requirements, follow procedures, evaluate documentation, and contribute to safety audits while working with internal and external inspectors.

Key Responsibilities

• Play a key role in the hands-on execution of plant operations while providing valuable support to Manufacturing Associates in troubleshooting and resolving issues.
• Monitor and analyze processing parameters to identify trends and uncover opportunities for process optimization and improvement.
• Prepare solutions and equipment, ensuring smooth operation and efficiency.
• Stage components for autoclaving and washing, contributing to the production flow.
• Assist in the testing of production samples and leverage any experience with analytical instruments to enhance process accuracy.
• Actively participate in continuous improvement initiatives, helping to drive operational excellence.
• Contribute to safety audits and ensure that all activities align with industry standards and regulations.
• Ensure strict adherence to EHS, regulatory, and GMP requirements, maintaining a high level of compliance.
• Follow written procedures, quickly recognize malfunctions, and take prompt action to report and resolve issues.
• Evaluate documentation and data in line with company and regulatory guidelines, ensuring accuracy and compliance.
• Engage with internal and external inspectors, maintaining open communication and fostering transparency.
• Apply your knowledge of GMP to ensure the highest standards of production practices.
• Use basic statistical and mathematical skills to analyze data and make informed decisions.
• Effectively organize tasks, manage multiple priorities, and meet deadlines in a fast-paced environment.
• Leverage your understanding of basic chemistry, biology, and physical principles to support various plant operations.
• Have a solid grasp of analytical methods to ensure precision and quality in production.

Required Qualifications

• Diploma in Science or Engineering.
• NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences, or Bio-processing-related disciplines.
• Fresh graduates are highly encouraged to apply.
• Proficiency in reading and writing English.
• Strong commitment to cGMP and EHS compliance in clean-room plant operations (prior experience with cGMP is a plus).
• Knowledge of plant and unit operations (e.g., autoclaves, parts washers, process equipment) and strong problem-solving skills.
• Excellent self-motivated team player with a hands-on attitude and effective communication skills.
• Familiarity with systems like Emerson DeltaV, LIMS, and TrackWise.
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles.
• Willingness to work shifts, including 24/7 operations.
• Strong mechanical ability and expertise.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Project Coordinator (PC) supports the Project Manager in delivering warehouse and logistics-related projects, ensuring alignment with scope, schedule, cost, quality, safety, and compliance requirements. The role focuses on coordination, monitoring, and governance of project activities across design, procurement, construction, commissioning, and turnover phases. The PC acts as a key interface between internal stakeholders, contractors, and vendors, ensuring smooth execution, issue resolution, and adherence to design intent and regulatory standards. The role covers warehouse infrastructure including freezers, weighing and dispensing systems, logistics flow (including automation such as AGVs), and related support systems.

Key Responsibilities

• Coordinate project workstreams across design, procurement, construction, commissioning, and qualification phases
• Act as primary interface between internal stakeholders, contractors, vendors, and functional teams
• Facilitate cross-functional coordination meetings and ensure alignment across engineering, operations, QA, EHS, and other functions
• Track project schedule, identify delays, manage critical path activities, and support recovery planning
• Monitor project budget, commitments, forecasts, and cost variances
• Support change management processes including scope, cost, schedule, and quality impacts
• Maintain and track project risks, issues, and mitigation actions
• Coordinate site activities including construction progress, logistics, and installation readiness
• Oversee contractor performance, ensuring quality, compliance, and adherence to specifications
• Ensure proper document control, including review, approval, and version management
• Prepare project status reports, dashboards, and presentations for governance forums
• Support stakeholder communication, expectation management, and decision-making processes
• Coordinate commissioning and qualification readiness, including system turnover and handover activities
• Ensure smooth transition from construction to commissioning and operations

Required Qualifications

• Degree in Engineering, Project Management, or related technical discipline
• Experience coordinating or supporting project work packages in engineering or construction environments
• Strong understanding of project scheduling, cost tracking, and progress monitoring
• Experience coordinating site activities, contractor works, and installation readiness
• Ability to interpret technical drawings, specifications, and project documentation
• Knowledge of engineering standards, GMP/GEP principles, and safety requirements
• Strong communication skills with ability to manage stakeholders and escalate issues effectively
• Good analytical and problem-solving skills with ability to manage multiple priorities
• Experience in warehouse, logistics, or infrastructure-related projects (preferred)
• Exposure to construction, facility build, or equipment installation environments (preferred)

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Validation Support role is responsible for supporting validation lifecycle activities across direct, indirect, and no-impact systems within a regulated pharmaceutical environment. The position ensures that equipment and systems remain in a qualified state through ongoing validation maintenance reviews, execution of qualification and requalification activities, and coordination with cross-functional stakeholders such as QA and QC. This role plays a key part in maintaining compliance with GMP requirements and ensuring validation documentation and processes are properly executed, reviewed, and approved.

Key Responsibilities

• Perform Validation Maintenance Reviews for direct, indirect, and no-impact systems
• Generate, review, and approve validation documentation (e.g. DQ, IQ, OQ, PQ) for new equipment qualification
• Plan and execute periodic requalification protocols for temperature chambers using data loggers/sensors
• Coordinate with cross-functional stakeholders (QA, QC, Engineering) to plan and align execution schedules
• Ensure validation activities are executed in compliance with GMP and internal quality standards
• Support audit readiness by maintaining accurate and complete validation documentation

Required Qualifications

• Diploma or Degree in Engineering, Life Sciences, Pharmacy, or related field
• Experience in validation or qualification activities within a GMP-regulated environment (pharma, biotech, medical devices)
• Familiarity with validation documentation (DQ, IQ, OQ, PQ)
• Understanding of temperature mapping, calibration, or equipment qualification processes
• Strong attention to detail and documentation accuracy
• Good communication skills for cross-functional coordination (QA/QC/Engineering)
• Ability to manage multiple tasks and meet project timelines

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking an experienced Computer System Validation (CSV) Specialist with strong expertise in isolator systems to support validation activities within a regulated life sciences environment. The successful candidate will play a key role in ensuring that automated systems associated with isolators are validated in compliance with regulatory expectations and industry best practices, using a paper-based validation approach.

Key Responsibilities

• Lead and execute CSV activities for isolator systems and associated software platforms
• Develop and review validation deliverables, including:
  - Validation Plans / Validation Master Plans (VMP)
  - User Requirements Specifications (URS)
  - Functional / Design Specifications (FS/DS)
  - Risk Assessments (GAMP 5 aligned)
  - IQ/OQ/PQ protocols and reports
  - Traceability Matrices
• Support system lifecycle validation from design through to decommissioning
• Apply risk-based validation approaches in line with industry standards
• Execute and manage paper-based validation documentation and approvals
• Collaborate with cross-functional teams (Engineering, Automation, QA, Vendors) to ensure alignment on validation scope and execution
• Review and assess vendor documentation for compliance and adequacy
• Support deviations, CAPA, and change control related to validated systems
• Ensure compliance with applicable regulatory standards (e.g., GxP, 21 CFR Part 11, Annex 11)

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline
• 3–8 years of experience in CSV within pharmaceutical / biotech environments
• Strong hands-on experience in isolator systems validation
• Familiarity with automation systems (e.g., PLC, SCADA, HMI) linked to isolators
• Experience working in a paper-based validation environment
• Good understanding of data integrity principles (ALCOA+)
• Experience with GAMP 5 and validation lifecycle methodologies
• Strong documentation and stakeholder communication skills

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a Qualification Engineer lead commissioning, qualification, and validation (CQV) activities for HVAC systems, cleanrooms, and critical utilities within a GMP-regulated pharmaceutical environment.

The role will focus on end-to-end qualification lifecycle execution, ensuring compliance with EU GMP Annex 15, ASTM E2500, and industry best practices.

Key Responsibilities

• Commissioning & Qualification Execution
  - Support CQV lifecycle activities for HVAC, cleanrooms, and utilities systems (e.g., PW, WFI, Clean Steam, compressed air).
  - Execute IQ, OQ, and PQ protocols for facilities and utilities systems.
  - Participate in commissioning activities including system walkdowns and punch listing.
  - Perform functional testing and verification of system performance.
• Documentation & Protocol Development
  - Develop and/or execute qualification documents: URS (review), SIA (System Impact Assessment), Risk Assessments / Criticality Assessments
  - DQ, IQ, OQ, PQ protocols and reports
  - Ensure traceability through RTM (Requirements Traceability Matrix)
• HVAC & Cleanroom Qualification
  Perform or support:
  - Airflow visualization (smoke studies)
  - HEPA filter integrity testing (PAO/DOP)
  - Air velocity and air change rate verification
  - Temperature and humidity mapping
  - Room pressure cascade verification
• Utilities Qualification
  - Support qualification of:
  - Water systems (PW/WFI loops)
  - Clean steam systems
  - Compressed gases (CDA, nitrogen, oxygen)
  - Execute sampling and testing activities in collaboration with QA/QC teams
• Stakeholder Coordination
  Work closely with:
  - Engineering / Facilities teams
  - Vendors and system integrators
  - QA/Validation teams
  - Support FAT/SAT activities where required
• GMP Compliance & Quality
  - Ensure all activities comply with:
  - cGMP requirements
  - Data integrity (ALCOA+) principles
  - Support deviations, CAPA, and change control activities

Required Qualifications

• Education
  Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related discipline)
• Experience
  ~5 years of relevant CQV/Validation experience in pharmaceutical or biotech industry
• Hands-on experience in
  - HVAC / cleanroom qualification
  - Utilities systems qualification
  - Technical Skills
• Familiar with
  - EU GMP Annex 15
  - ASTM E2500
  - ISPE Baseline Guides (Volume 5 – Commissioning & Qualification)
• Strong understanding of
  - HVAC systems and cleanroom classifications (Grade A–D)
  - Utilities systems design and operation
• Soft Skills
  - Strong documentation and technical writing skills
  - Good stakeholder management and communication skills
  - Ability to work independently and in cross-functional teams

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The QA Validation professional provides quality oversight, review, and approval of validation and qualification activities to ensure compliance with GMP, regulatory expectations, and internal quality systems. This role ensures that validation deliverables are scientifically sound, risk-based, and inspection-ready, while supporting cross-functional project execution in a GMP-regulated environment.

Key Responsibilities

• Provide QA oversight for equipment, facility, utility, process, and cleaning validation and qualification activities
• Ensure validation approaches align with GMP, data integrity principles, and regulatory guidelines (e.g., FDA, EMA, PIC/S).
• Review validation strategies to ensure compliant, risk-based execution.
• Review and approve validation lifecycle documentation, including:
  - Validation Master Plan (VMP)
  - Risk assessments (e.g., FMEA, SRA)
  - URS, DQ, IQ, OQ, PQ
  - Cleaning validation protocols and reports
• Computer System Validation (CSV) documents, where applicable
• Ensure validation documentation is complete, traceable, and audit-ready
• Review and assess validation-related deviations, non-conformances, and investigations.
• Ensure appropriate root cause analysis and CAPA implementation.
• Support change control activities and assess validation impact.
• Support internal, customer, and regulatory inspections related to validation scope.
• Act as a QA validation subject matter representative during audits.
• Support timely closure of validation-related audit observations.
• Collaborate closely with Engineering, CQV, Manufacturing, QC, IT, and external vendors.
• Provide QA guidance during project phases, including new equipment introduction, upgrades, and revalidation.
• Support project timelines while maintaining compliance.
• Contribute to continuous improvement of validation and QA processes.
• Support updates to SOPs, templates, and validation standards.
• Promote a strong quality culture and right-first-time mindset.

Required Qualifications

• Diploma or Bachelors degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• 3–8+ years of experience in QA Validation, CQV, or Quality Assurance within GMP-regulated environments.
• Hands-on experience reviewing validation documentation for:
  - Process equipment
  - Utilities (e.g., WFI, clean steam, compressed gases)
  - Facilities and cleanrooms
  - Cleaning validation
• Experience with Computer System Validation (CSV) is an advantage.
• Strong understanding of GMP, data integrity, and validation lifecycle concepts.
• Familiarity with FDA, EMA, and PIC/S regulatory expectations.
• Strong documentation review and compliance mindset.
• Ability to challenge constructively while enabling project delivery.
• Good stakeholder engagement and communication skills.
• Detail-oriented, structured, and inspection-focused.
• Comfortable working in project-based and fast-paced environments.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are looking for a detail-oriented and results-driven Downstream Engineer to join our dynamic team. In this role, you will be responsible for the development, optimization, and support of downstream processing systems to ensure efficient product recovery, purification, and operational excellence. You will work closely with cross-functional teams to support both day-to-day manufacturing and long-term process improvements, contributing to the successful delivery of high-quality products in a GMP-regulated environment.

Key Responsibilities

• Design, develop, and optimize downstream processes (e.g., filtration, chromatography, centrifugation) for large-scale production.
• Apply engineering principles to recommend, design, and implement new equipment or system modifications.
• Work closely with cross-functional teams including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to drive operational improvements.
• Provide technical support to commercial manufacturing operations as needed.
• Troubleshoot and resolve equipment, automation, or process-related issues in the field.
• Ensure optimal and cost-effective performance and reliability of process systems.
• Develop, organize, analyze, and present results for operational issues and engineering projects of moderate scope and complexity.
• Proactively communicate with supervisors and cross-functional partners, highlighting issues and proposing practical solutions.
• Act as a technical expert to help introduce advanced technologies and "Next Generation Manufacturing" approaches into the plant.
• Manage change controls, deviations, CAPAs, and process equipment documentation.
• Oversee implementation, development, and changes related to process equipment Commissioning, Qualification, and Validation (CQV).
• Prepare, coordinate, and present complex technical data at cross-functional meetings and management reviews.
• Provide on-call technical support as required.

Required Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Bioprocess Engineering, Biotechnology, or a related field
• Minimum 2+ years of experience in downstream processing, preferably in a GMP-regulated environment
• Hands-on experience with purification techniques such as chromatography, ultrafiltration/diafiltration, and virus filtration
• Familiarity with change control systems, validation processes, and deviation management
• Strong analytical and troubleshooting skills
• Excellent communication and interpersonal skills
• Ability to work effectively in cross-functional teams with a collaborative mindset

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Technical Writer (CQV) is responsible for the development, review, and management of commissioning, qualification, and validation (CQV) lifecycle documentation within a regulated pharmaceutical or biotechnology environment. This role ensures that all documentation is aligned with GMP requirements and industry standards, supporting equipment, utilities, and system validation activities. The Technical Writer works closely with cross-functional teams, including Engineering, QA, and Automation, to gather technical inputs, maintain document integrity, and support project timelines. This is a hands-on role requiring strong attention to detail, compliance awareness, and the ability to manage documentation across multiple project phases.

Key Responsibilities

• Develop and review CQV lifecycle documents, including URS, DQ summaries (as applicable), IQ, OQ, and PQ protocols and reports
• Author validation protocols and reports in accordance with site procedures and regulatory expectations
• Ensure proper document formatting, version control, and traceability throughout the document lifecycle
• Coordinate with CQV engineers, QA, and project stakeholders to gather and verify technical inputs
• Support document revisions, approvals, and close-out activities to meet project timelines
• Ensure documentation aligns with GMP (EU/FDA), Annex 15, ASTM E2500, and site-specific quality systems
• Maintain audit-ready documentation by ensuring completeness, accuracy, and compliance
• Track documentation status and support timely delivery of validation deliverables
• Assist in risk assessments, traceability matrices (RTM), and change control documentation
• Collaborate with cross-functional teams including Engineering, QA, Automation, and external vendors

Required Qualifications

• Degree or Diploma in Engineering, Life Sciences, or a related discipline
• 3–5 years of experience in CQV documentation within the pharmaceutical or biotechnology industry
• Proven experience in authoring IQ/OQ/PQ protocols and reports
• Strong understanding of GMP requirements and validation lifecycle principles
• Experience with qualification of process equipment, utilities, or cleanroom systems
• Familiarity with URS, RTM, and risk assessment methodologies
• Exposure to electronic documentation systems (e.g., Veeva, Kneat, TrackWise) is an advantage

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The CSV (Computer System Validation) Engineer is responsible for ensuring that computerized systems used in regulated environments are validated and maintained in compliance with applicable regulatory requirements and company standards. This role supports the full validation lifecycle, including planning, execution, documentation, and maintenance of validation activities for systems such as MES, BAS, and process control systems. The CSV Engineer works closely with cross-functional teams to ensure system reliability, data integrity, and compliance with cGxP guidelines while supporting project timelines and operational readiness.

Key Responsibilities

• Develop, review, and execute CSV deliverables including validation plans, risk assessments, protocols (IQ/OQ/PQ), and summary reports

• Perform validation activities for computerized systems (e.g., MES, BAS, DCS, LIMS) in compliance with regulatory standards (e.g., GAMP5, 21 CFR Part 11)

• Review and implement change controls related to computerized systems, ensuring validated state is maintained

• Evaluate and approve system configuration and changes for platforms such as Syncade, DeltaV, BAS, and other automation systems

• Investigate deviations, discrepancies, and validation issues, ensuring timely resolution and proper documentation

• Support periodic review and lifecycle management of validated systems using tools such as Kneat or equivalent

• Collaborate with QA, IT, Automation, and Engineering teams to ensure alignment on validation strategy and execution

• Ensure data integrity, audit trail review, and compliance with internal and external regulatory requirements

• Support audits and inspections by providing necessary CSV documentation and justifications

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field

• Experience in Computer System Validation within pharmaceutical, biotech, or regulated industries

• Strong knowledge of GxP, GAMP5, and 21 CFR Part 11 requirements

• Experience with validation lifecycle documentation and execution (IQ/OQ/PQ)

• Familiarity with systems such as MES (e.g., Syncade), DeltaV, BAS, LIMS, or similar platforms

• Experience with validation management tools (e.g., Kneat) is an advantage

• Strong problem-solving, analytical, and documentation skills

• Good communication skills and ability to work with cross-functional teams

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Facilities Engineer role is responsible for overseeing the overall maintenance, cleanliness, and operational readiness of site facilities within a GMP-regulated environment. This position ensures that all building systems, soft services, and vendor-managed services are effectively coordinated and meet established quality, safety, and compliance standards. The role also supports operational excellence by managing service contracts, driving continuous improvement initiatives, and ensuring facility readiness for audits, while contributing to sustainability efforts and employee engagement activities across the site.

Key Responsibilities

• Oversee facility operations including building maintenance, cleanroom upkeep, fire protection, security systems, pest control, janitorial, and cGMP cleaning services
• Manage vendor relationships, establish KPIs, conduct audits, and ensure service delivery meets agreed SLAs
• Implement and maintain customer service feedback mechanisms for timely issue resolution
• Participate in SQDIP and production coordination meetings as required
• Manage facilities work orders for routine and non-routine maintenance activities
• Ensure cleanliness standards across all facility zones in compliance with QA requirements
• Coordinate pest control programs and lead investigations for any pest-related incidents
• Plan and coordinate schedules for operations, maintenance, and administrative staff
• Develop, maintain, and improve facilities-related SOPs
• Supervise contractors and monitor performance against established KPIs
• Support audit readiness by preparing audit and war rooms and ensuring facility compliance
• Own and manage Non-Conformances (NC) and CAPA related to facilities services
• Deliver training and maintain records in compliance with SOPs and GxP requirements
• Collaborate with EHSS on sustainability initiatives and environmental programs
• Drive facility improvement and cost-saving projects
• Manage soft services including courier services, stationery, meeting rooms, pantry, café, and transport services
• Participate in emergency response team activities and EHS training
• Lead site-wide engagement activities and events to promote a positive workplace environment

Required Qualifications

• Master's degree in Engineering or Facilities Management; OR
• Bachelor's degree in Engineering or Facilities Management with at least 2 years of relevant experience in a GMP environment; OR
• Associate's degree in Engineering or Facilities Management with at least 6 years of relevant experience in a GMP environment; OR
• High school diploma/GED with at least 8 years of relevant experience in a GMP environment
• Familiarity with documentation practices in a highly regulated environment
• Knowledge of NC, CAPA, Change Control, and engineering documentation/records management
• Experience in managing contractors and vendors
• Strong interpersonal and communication skills
• High level of computer literacy
• Strong customer service orientation

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Project Controller will support the Client Project Manager in overseeing the financial management and cost control of the project. This role is responsible for monitoring project expenditures, forecasting future costs, coordinating with finance teams and EPCM contractors, and ensuring accurate and timely financial reporting throughout the project lifecycle while maintaining strong financial governance and transparency.

Key Responsibilities

• Maintain accurate tracking of project costs and expenditures on a monthly basis
• Prepare and update financial reports, including cost status, forecasts, and cash flow projections
• Support cost forecasting and financial planning with the Client Project Manager
• Ensure financial control and transparency across the project lifecycle
• Review and validate EPCM contractor claims and cost submissions
• Monitor project spending against progress and forecast upcoming costs
• Provide monthly project controlling reports and weekly financial updates
• Highlight financial risks and propose mitigation strategies
• Coordinate with site finance teams to ensure compliance with financial policies and accounting practices
• Support financial processes such as VOWD accruals, asset capitalization, project closure, and fixed asset management
• Collaborate with finance teams on asset activation/deactivation, depreciation, and impairment assessments
• Support CAPEX project controlling and ensure accurate financial tracking of capital projects

Required Qualifications

• Degree or diploma in Finance, Accounting, Engineering, or Project Management
• Minimum 5 years of experience in Project Controls or Project Financial Management
• Experience supporting large capital or engineering projects
• Familiarity with capital project financial management and fixed asset accounting
• Experience with SAP or equivalent financial systems preferred
• Strong knowledge of cost control, financial forecasting, and accounting principles (e.g., GAAP)
• Strong analytical, reporting, and problem-solving skills
• Ability to coordinate across multiple stakeholders and teams
• Good communication and stakeholder management skills

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The EMS CQV Engineer will support the commissioning, qualification, and validation (CQV) of the Environmental Monitoring System (EMS) within a regulated pharmaceutical or biotechnology project environment. This role focuses on ensuring that EMS systems are installed, tested, and documented in compliance with GMP and site quality standards. The engineer will work closely with cross-functional teams, including automation, vendors, and facility engineering, to ensure timely project delivery while maintaining high standards of compliance and documentation integrity.

Key Responsibilities

• Support commissioning, qualification, and validation (CQV) activities for the EMS system
• Prepare and execute CQV documentation, including FAT/SAT, IQ, and OQ protocols and reports
• Ensure all documentation complies with GMP and site quality requirements
• Act as the CQV point of contact for the EMS package during the project phase
• Coordinate with system vendors, automation teams, and facility engineering teams
• Track, manage, and resolve CQV punch list items and deviations
• Support project timelines by ensuring CQV activities are completed as scheduled
• Participate in project meetings and technical discussions with cross-functional stakeholders
• Provide regular progress updates and proactively highlight risks or delays
• Ensure EMS qualification aligns with regulatory expectations and internal procedures
• Support change control processes, deviations, and documentation reviews as required

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline
• Proven experience in CQV within the pharmaceutical or biotechnology industry
• Hands-on experience with EMS (Environmental Monitoring Systems) qualification preferred
• Strong knowledge of GMP and regulatory requirements (e.g., FDA, EMA)
• Experience in preparing and executing validation documentation (IQ/OQ, FAT/SAT)
• Familiarity with change control, deviation management, and documentation practices
• Ability to work in a cross-functional, project-based environment
• Strong communication and stakeholder coordination skills
• Detail-oriented with strong organizational and problem-solving abilities

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Project Scheduler will support the Client's Project Manager in the planning, coordination, and control of the project schedule. This role is responsible for developing and maintaining the integrated project schedule, tracking progress against key milestones, and ensuring alignment across multiple workstreams. The Project Scheduler will work closely with cross-functional stakeholders to collect progress updates, perform schedule analysis, and proactively identify and mitigate schedule risks to support effective project execution. The role will commence on a part-time basis from April to September 2026 (8 hours/day, 2 days/week) and transition to full-time support from October 2026 to January 2027 (8 hours/day, 5 days/week) in line with project requirements.

Key Responsibilities

• Develop, maintain, and update the overall project schedule using Primavera P6 or equivalent tools
• Perform weekly schedule updates incorporating progress from execution teams
• Reforecast project timelines based on actual progress and evolving conditions
• Maintain and update S-curve progress tracking for commissioning and qualification activities
• Develop and manage detailed schedules for project shutdown activities
• Coordinate with stakeholders to ensure all shutdown-related activities are captured and aligned
• Identify and manage activity dependencies across multiple functions
• Establish schedule baselines and ensure alignment with execution strategy
• Monitor schedule changes and conduct impact analysis on critical path activities
• Identify potential delays and risks early, and support mitigation planning
• Provide weekly schedule updates, including critical path and risk analysis, to the Client Project Manager
• Communicate schedule updates clearly to stakeholders and escalate risks when necessary
• Collaborate with engineering, construction, commissioning, and operations teams for accurate progress tracking

Required Qualifications

• Degree or diploma in Engineering, Project Management, Construction Management, or a related discipline
• Proven experience as a Project Scheduler in large-scale capital or engineering projects
• Experience working in complex, multi-stakeholder project environments
• Experience in pharmaceutical, biotech, or regulated industries is advantageous
• Proficiency in Primavera P6 or similar project scheduling tools preferred
• Strong understanding of scheduling methodologies and critical path analysis
• Excellent stakeholder communication and coordination skills
• Ability to integrate and manage schedules across multiple workstreams
• Strong analytical and problem-solving skills

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.