Total 5 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

The Maintenance Equipment Engineer is responsible for ensuring the reliability, availability, and compliance of manufacturing equipment within the API plant. This role supports maintenance strategies, troubleshooting, and continuous improvement to ensure safe, efficient, and GMP-compliant operations.

Key Responsibilities

1. Equipment Reliability & Maintenance

• Develop and implement preventive and predictive maintenance programs for API manufacturing equipment
• Ensure high equipment uptime and reliability to support production targets
• Troubleshoot and resolve equipment breakdowns in a timely manner

2. Maintenance Strategy & Optimization

• Drive continuous improvement initiatives to enhance equipment performance (MTBF, MTTR)
• Support root cause analysis (RCA) and implement corrective and preventive actions (CAPA)
• Optimize maintenance plans based on data, equipment history, and criticality

3. GMP Compliance & Documentation

• Ensure all maintenance activities comply with cGMP, EHS, and internal quality standards
• Maintain accurate documentation including maintenance records, SOPs, and logbooks
• Support audit readiness and regulatory inspections (e.g., FDA, EMA)

4. Equipment Support & Technical Expertise

• Provide technical support for process equipment
• Liaise with equipment vendors and contractors for maintenance, repair, and upgrades
• Support commissioning, qualification (IQ/OQ/PQ), and validation activities

5. Cross-functional Collaboration

• Work closely with Production, Engineering, QA, and Validation teams
• Support deviation investigations related to equipment failures
• Participate in cross-functional projects for process improvement and plant upgrades

6. Project & Change Management

• Support or lead engineering projects related to equipment upgrades, replacements, and modifications
• Manage change control processes in compliance with GMP requirements
• Ensure timely execution of maintenance-related CAPEX and improvement projects

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or related discipline
• 3–8 years of experience in pharmaceutical, API, or chemical manufacturing environment
• Strong understanding of GMP requirements and regulated industry standards
• Experience in maintenance of process equipment in API manufacturing

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

We are seeking a Utilities Engineer to ensure the proper maintenance and compliance of facility systems and equipment according to design specifications and GMP standards. The engineer will provide technical expertise for the operation and maintenance of utilities systems, supporting routine operations readiness. Responsibilities include ensuring adherence to standards, supporting the development of commissioning and qualification documents, and ensuring compliance with regulatory requirements. The role also involves troubleshooting technical issues, collaborating with cross-functional teams, and promoting knowledge sharing.

Key Responsibilities

Operational Excellence, Continuous Improvement, and Daily Operations

• Lead and support continuous improvement initiatives for utility system operations, maintenance, and reliability programs.
• Establish key metrics to ensure optimal performance of utility operations.
• Lead and support utility projects by reviewing engineering design documentation and related drawings.
• Lead and support Site Acceptance Tests (SAT), commissioning, and system testing to meet User Requirement Specifications (URS).
• Participate in system walk-downs to ensure reliable utility system operations.
  

Safety and Quality Compliance Management

• Lead and support audit readiness activities for regulatory inspections to ensure compliance with site and global SOPs, GEP, and GDP requirements.
• Assist in the development, revision, review, and approval of Standard Operating Procedures (SOPs), Risk Assessments, Preventive Maintenance Programs, and Job Plans.
• Lead and support deviation investigations, ensuring appropriate Corrective and Preventive Actions (CAPA) are implemented.
• Lead and support change control activities and continuous improvement initiatives to enhance system reliability and operational performance.
• Actively promote and uphold the Company's Safety Culture.

Sustainability

• Lead and support site sustainability initiatives through analysis of utility and energy consumption data.
• Identify opportunities to optimize utility usage and improve energy efficiency.
• Support the development of business cases and proposals to achieve site sustainability objectives.
• Generate and compile utility consumption data for regulatory authority submissions and internal reporting.

Required Qualifications

• Diploma or Degree in Mechanical, Electrical, Chemical, or related Engineering disciplines.
• Ability to work independently and collaboratively within cross-functional teams.
• Strong interpersonal, communication, and presentation skills.
• Proficient in computer applications and documentation systems.
• Experience working in a highly regulated environment with GMP documentation practices.
• Strong analytical and problem-solving capabilities with the ability to identify improvement opportunities.
• Effective stakeholder management and facilitation skills to achieve project and operational objectives.
• Ability to influence and collaborate positively with peers and stakeholders.
• Familiarity with utilities systems, maintenance programs, commissioning, qualification, and compliance requirements within pharmaceutical, biotech, or related manufacturing environments is 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

We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer with strong experience in aseptic and sterile manufacturing environments. The successful candidate will be responsible for executing CQV activities across equipment, utilities, and cleanroom systems, ensuring compliance with GMP and regulatory requirements.

Key Responsibilities

• Execute commissioning and qualification (IQ/OQ/PQ) activities for process equipment, clean utilities, and facilities in aseptic manufacturing areas.
• Develop, review, and approve validation protocols and reports in alignment with GMP, FDA, and EU regulatory requirements.
• Support aseptic processes, including cleanroom qualification, HVAC systems, and environmental monitoring (EM).
• Perform risk assessments (e.g., FMEA, impact assessments) to define validation strategies.
• Ensure compliance with sterility assurance requirements, including contamination control and aseptic processing guidelines.
• Collaborate with cross-functional teams (Engineering, QA, Production) to support project timelines and deliverables.
• Manage and support deviations, CAPA, and change controls related to CQV activities.
• Participate in FAT/SAT activities, ensuring systems meet user requirements specifications (URS).
• Support regulatory audits and inspections, providing documentation and technical justifications where required.
• Ensure all documentation is maintained in accordance with data integrity (ALCOA+) principles.

Required Qualifications

• Bachelor's Degree in Engineering, Life Sciences, or related discipline.
• Minimum 3–5 years of CQV experience within the pharmaceutical or biotechnology industry.
• Hands-on experience in aseptic or sterile manufacturing environments (e.g., fill-finish, cleanroom operations).
• Strong knowledge of GMP regulations, Annex 1, FDA guidelines, and validation lifecycle.
• Experience with clean utilities (WFI, clean steam, compressed gases) and HVAC systems.
• Familiar with EM programs, cleanroom classifications, and contamination control strategies.
• Proven experience in protocol writing and execution.
• Strong problem-solving skills and ability to handle deviations and investigations.
• Excellent 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 CQV Engineer is responsible to support commissioning, qualification and validation activities for GMP process equipment and utilities in a pharmaceutical / biotechnology environment. Focus on equipment such as stainless steel vessels, CIP/SIP systems, thermal systems and related process utilities. Prepare, execute, review and close CQV documentation in line with GMP, GDP and project requirements.

Key Responsibilities

• Prepare and execute CQV documents, including: Commissioning protocols, IQ / OQ / PQ protocols, Test scripts, Qualification reports, Deviation reports, Traceability matrices
• Support qualification of stainless steel vessels, including: Mixing vessels, Holding tanks, Buffer / media preparation vessels, Process tanks, Product-contact equipment
• Perform Material of Construction checks for stainless steel equipment, including verification of: MOC certificates, Surface finish, Welding documentation, Passivation records, Product-contact parts, Gasket / seal materials
  
• Support CIP and SIP qualification, including: Cycle verification, Sprayball coverage checks, Flow / pressure / temperature verification, Conductivity checks, Hold time verification, Drainability checks, Sterilisation cycle assessment
• Support thermal mapping / temperature qualification activities for GMP equipment and systems.
• Execute qualification testing and document results in accordance with approved protocols.
• Use Kneat for protocol execution, review, comment resolution and document lifecycle management.
• Support FAT / SAT, commissioning walkdowns and system handover activities.
• Review vendor documents, drawings, P&IDs, datasheets, manuals and calibration records.
• Raise and support closure of deviations, punch items, non-conformities and qualification discrepancies.
• Work with QA, Engineering, Manufacturing, Automation, Vendors and Project teams to ensure timely CQV completion.
• Ensure all qualification activities comply with GMP, GDP, data integrity and site SOP requirements.

Required Qualifications

• Degree / Diploma in Engineering, Biotechnology, Pharmaceutical Science, Life Sciences or related discipline.
• 3 to 5 years of relevant CQV experience in pharmaceutical, biotech, biologics or GMP manufacturing environment.
• Hands-on experience with CIP, SIP, thermal mapping and stainless steel process equipment.
• Experience performing Material of Construction checks for GMP equipment.
• Familiar with IQ / OQ / PQ execution and GMP documentation requirements.
• Experience using Kneat for validation document execution and review.
• Able to read and understand P&IDs, equipment drawings, datasheets and vendor technical documents.
• Good understanding of GMP, GDP, deviation management and change control.
• Strong documentation discipline and attention to detail.
• Able to work independently on site and coordinate 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

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.