Total 6,982 software engineer job vacancies in Engineering category in Singapore

Key Skills & Responsibilities:

• Strong backend experience in Java and EAPI
• Frontend development using React
• Expertise in REST APIs and Microservices
• Production support, troubleshooting, and debugging
• Experience with CI/CD pipelines, automated testing, and deployments
• Ability to deliver high-performance, scalable, and secure applications

• Responsible for piping layout and engineering related activity not limited to Pipe and Pipe support design, Piping Material Handling activity,Piping Material Engineering activities like MTO (bulks, manual valves, SP items, Pipe Support), Requisitions, Supplier drawings review, Pipe Stress Analysis activities like preparation of stress critical line list, analysis using Caesar II, report preparation, Spring data sheet preparation, supplier drawing reviews, pipe isometric and pipe support checking, piping line listpreparation etc
• Coordinate on project specific issues with the respective subject specialist Lead
• Be responsible for the technical integrity for compliance to project HSE requirements relevant to the scope of work.
• Work closely with the piping lead / subject specialist lead of the project to understand their requirements and address on time. Develop reports as required by the lead.
• In case of any technical challenges, troubleshoot to resolve the issues on time and if required escalate to subject specific lead for quick resolution.Plan tasks and issue the deliverables as per company procedures.
• Issue of discipline deliverables in project specific templates.
• Be familiar with the workflows in the project. Taking initiative and provide any input to the Piping Lead / Subject specialist lead on time and highlight in advance if there are any technical challenges.
• Coordinate actively with other offices, for the projects being executed from multiple locations, attend meetings, and communicate effectively.
• Review and provide technical inputs as required by the Project.
• Based on the client specifications, follow project specific procedure related to Piping Layout and Engineering.
• Be responsible for the deliverables and to ensure that the design complies with the specification, integrity, and quality requirements of the project.
• Be responsible in finalization piping systems requirements such as, PED and testing requirements of NDT, hydro and pneumatic in line with the project requirements.
• Be responsible to procurement support for the Piping components, the activities vary from finalization of MTO, placing purchase orders in the systems, valuation of technical offers from the suppliers and ensuring the timely delivery with full project compliance.
• Be responsible for and manage the technical interfaces with equipment and package suppliers, as appropriate, to ensure compliance to Standards &Project Specifications
• Provide technical support to the project to obtain necessary approvals from the verification body / classification society or other applicable approving authorities.
• Represent Piping Discipline in meetings, discussions, audits, verifications, workshops, and technical reviews that relates to piping and be responsible for closeout of actions identified as required.
• Be responsible to align to the progress of Piping Engineering scope and internal and supplier deliverables, where applicable, as per the schedule of the project.
• Be responsible for Management of change within the scope of work for the Piping Discipline on assigned projects.
• In case of any technical challenges, troubleshoot to resolve the issues on time and if required escalate to piping material lead for quick resolution.Plan tasks and issue the deliverables as per company procedures.
• Issue of discipline deliverables in project specific templates.

Work Experience

• Must have a minimum of 12 years of experience having worked in an engineering setup for upstream oil & gas projects (platforms & FPSO projects) serving in the capacity of a Senior Piping Engineer.
• Experience in Software usage for Piping material quantity estimate, Procurement planning, CaesarII, E3D, Navis etc. material traceability and delivery to site.
• Experience in Norwegian projects and applicants experience tothe relevant standards, NCS and UKCS sectors preferred.
• Must have had prior work experience with medium/large sized brownfield and green field projects in the Oil and Gas sector with similar roles and possess an excellent understanding of project phases, milestones, and deliverables.
• Must have in-depth knowledge in Piping and cost-effectiveness, with a proven track record on projects in the upstream oil and gas sector.
• Must possess a thorough understanding and knowledgeof oil and natural gas industry standards suchas, but not limited to, ASME, API (American Petroleum Institute),BS, European Regulations and other relevant standards and guidelines.
• Experience in FPSO projects and HPHT services preferred.

Qualifications

• Must have a minimum bachelor’s degree in mechanical / Material Engineering or other equivalent engineering specialisation.

Other Skills

• Must possess design experience with respect to typical Piping Engineering deliverables, such as, specifications, data sheets (bulks, valves, SP items), MTO, TQ, TBA, Stress critical line list, Stressreports, Isometrics, Pipe Support Drawings, Piping Lists, and Supplier Drawing Reviews.
• Must have excellent technical communication (oraland written) skills with proven ability to present technical issues to designteams, client technical authorities, and client’s project managementrepresentatives and approving bodies.
• Must be a self-starter and be able to work withminimal supervision, make sound decisions, take independent action, analyseproblems, and provide focused solutions to assigned projects.
• Shall possess strong inter-personal andcommunication skills and be able to work well with people at all levels in theorganization.
• Have used common business software applications such as MS Office, MS Excel, Caesar II.
• Must be familiar with using Navisworks

We regret only short listed candidates will be notified.

Key Responsibilities:

full-stack engineer who can do Level 1 prod support work (Primary, ~20% of time ) and Development work (Secondary, ~ 80% of time)

1. Perform Level 1 production support work: E.g.

• Monitor mailbox for incoming support requests and inquiries.
• Perform simple triage of support tickets, categorizing and prioritizing them based on urgency and impact.

• Monitor and observe system alerts or out of the normal system behaviours.
• Verify system is performing after deployments

1. Design, build, integrate, test, and maintain complex software components
2. Build prototypes and design system architectures to demonstrate technology opportunities
3. Adopt design thinking and customer-oriented approach such as agile software development practices to manage and deliver quality solutions
4. Harness emerging technologies such as Artificial Intelligence to deliver business value and enhance service experience
5. Work with other UX designers, developers and engineers to deliver enterprise engineering products in an exciting and fast-paced environment
6. Deliver technical consultancy and expertise in the systems development process, contributing to defining technical specifications, configuring and testing solutions

Required Skills and Qualifications:

• Relevant qualifications in Computer Science, Information Systems, Computer Engineering, or related fields
• Good knowledge of agile development, DevOps and cloud technologies
• Experience in modern web and application technologies/stack (e.g. Nuxt, Node JS, Angular, React JS, Go)

• Experience in architecting and developing solutions to complex and ambiguous problems

• Passion for tech and curiosity in learning new technologies
• Excellent analytical and problem-solving skills
• Strong communication and interpersonal skills to collaborate with key stakeholders at all levels

Job Description

• Interpret contract specifications, architectural standards, and designs for construction
• Organise and lead meetings for design and construction; monitor and manage budgets; write reports; and carry out additional administrative duties associated with the projects that are allocated
• Oversee architectural planning, consulting coordination, and document control, including tracking sample submissions and drawing approval status
• Coordinate, organise and prepare construction and architectural documents and drawings
• Oversee architectural projects, communicate with clients and subcontractors regarding architectural issues, and guarantee the highest levels of architectural workmanship
• Provide the architectural designers with technical guidance on building requirements
• Organize and/or participate in subcontractor and consultant meetings

Requirements

• Min diploma in engineering
• Min 3 years of construction experience

About the Role

We are looking for a Senior Cybersecurity Engineer to work across two fronts: protecting our own systems, data, and customers, and delivering security projects for our clients. You will design and build security controls across multi-cloud environments (AWS and Azure), lead incident response, and partner with engineering teams to make security a built-in part of how software ships. On the client side, you will scope and deliver hands-on security engagements, advise customer stakeholders, and represent us as a trusted technical expert.

This is a hands-on technical role that balances internal security ownership with customer-facing project delivery, so comfort working directly with clients is essential.

What You'll Do

Internal security (our own environment)

• Design, implement, and maintain security controls across our AWS and Azure environments, covering identity (IAM, Azure AD/Entra ID), networking, encryption, logging, and workload protection.
• Build and enforce cloud security guardrails using native services (AWS Security Hub, GuardDuty, Azure Defender, Microsoft Sentinel) and cloud security posture management (CSPM) tooling.
• Lead detection and response efforts, including triage, investigation, containment, and post-incident review.
• Build and tune detection logic, alerting pipelines, and automation to reduce manual toil and improve mean time to detect and respond.
• Run and improve vulnerability management: scanning, prioritization, remediation tracking, and reporting.
• Develop and maintain security architecture standards, runbooks, and documentation.

Client project delivery

• Scope, plan, and deliver hands-on security engagements for customers (cloud security reviews, architecture design, hardening, assessments, and remediation).
• Serve as the technical lead and primary point of contact on client projects, translating requirements into deliverables.
• Advise customer stakeholders (engineers through executives) on risk, remediation, and security best practices.
• Conduct or coordinate penetration tests, configuration reviews, and red team exercises for clients, then drive remediation of findings.
• Produce clear, professional client-facing deliverables: assessment reports, architecture diagrams, and remediation roadmaps.
• Support compliance and audit work for clients, with a focus on Singapore government and regulated-sector frameworks (IM8, GCC/GCC+, MTCS, CCoP, PDPA, MAS TRM where relevant), alongside international standards (SOC 2, ISO 27001).

Cross-cutting

• Partner with software and infrastructure teams (internal and client) to embed security into the SDLC (threat modeling, secure code review, CI/CD security gates).
• Evaluate, deploy, and manage security tooling (SIEM, EDR, IDS/IPS, CSPM, secrets management, identity and access).
• Mentor junior engineers and raise security awareness across teams.

What We're Looking For

Required

• 5+ years of experience in cybersecurity, security engineering, or a closely related field.
• Strong knowledge of network security, operating system internals (Linux and Windows), and common attack and defense techniques.
• Deep hands-on experience securing AWS and Azure at scale: identity and access management, network segmentation (VPC/VNet, security groups, NSGs), key management, and workload and data protection.
• Proficiency with at least one scripting or programming language (Python, Go, Bash, or similar) for automation and tooling.
• Experience with detection and response: SIEM platforms, EDR tools, and log analysis at scale.
• Solid grasp of common frameworks and standards (MITRE ATT&CK, NIST CSF, OWASP Top 10, CIS Benchmarks).
• Working knowledge of Singapore government security and compliance requirements, including IM8 (Instruction Manual on ICT & SS Management, managed by GovTech), the Government on Commercial Cloud (GCC and GCC+) guardrails for AWS and Azure, MTCS (SS 584), the Cybersecurity Act and Cybersecurity Code of Practice (CCoP) for Critical Information Infrastructure, and the Personal Data Protection Act (PDPA).
• Strong analytical skills and the judgment to prioritize risk in a fast-moving environment.
• Clear written and verbal communication, with the ability to explain technical risk to non-technical stakeholders.
• Comfort working directly with clients: scoping engagements, managing expectations, and presenting findings to customer stakeholders.
• Ability to manage multiple concurrent projects and shift between internal work and client delivery.

Nice to Have

• Industry certifications (OSCP, GIAC/SANS, CISSP, CCSP, or equivalent), including cloud security certs (AWS Certified Security Specialty, Azure Security Engineer Associate AZ-500).
• Experience with infrastructure as code (Terraform, CloudFormation) and policy as code.
• Background in application security, threat modeling, or secure software development.
• Familiarity with container and Kubernetes security.
• Experience delivering projects under Singapore Government on Commercial Cloud (GCC/GCC+) or for CSA-regulated CII owners.
• Familiarity with CSA Cyber Essentials and Cyber Trust certification marks.
• Eligibility for Singapore government security clearance, where required for public-sector engagements.
• Hands-on penetration testing across multiple scopes: web applications, APIs, external and internal network/infrastructure, cloud configuration reviews (AWS and Azure), and mobile or wireless where applicable.
• Familiarity with common offensive tooling (Burp Suite, Nmap, Metasploit, Cobalt Strike, cloud-native testing tools) and structured methodologies (OWASP WSTG, PTES, NIST SP 800-115).
• Prior experience in a consulting, professional services, or managed security services (MSSP) environment.
• Prior experience leading incident response for production systems.
• Experience operating in a regulated or compliance-heavy environment.

What Success Looks Like

• In your first 90 days: you understand our environment, threat landscape, and tooling, and you have closed or improved several high-priority gaps.
• Within 6 months: you own key areas of our detection and response program and have measurably reduced risk in those areas.
• Within a year: you are a trusted technical leader who has shaped our security architecture and lifted the capability of the whole team.

• Perform process setup and buyoff for both Drive Backend Assembly, ensuring that yield, cycle time, and quality outcomes meet defined targets
• Support product ID label buyoff to ensure compliance with product specifications and standards• Monitor production yield to detect any excursions, conduct process mapping, and implement immediate containment (stop bleeding)
• Establish hypotheses, design experiments to identify root causes, propose corrective actions, and report findings to engineers
• Escalate process and technical issues appropriately per PMP requirements
• Conduct basic data queries and analysis to provide relevant information and insights for engineering teams
• Ensure process sustainability by monitoring KPIVs/KPOVs and managing Fast Triggering systems to maintain stable and controlled operations
• Lead or participate in continuous improvement projects aimed at enhancing production efficiency in a consistent and sustainable manner
• Perform additional tasks and responsibilities as assigned to support team, department, and company Objectives and Key Results (OKRs)

Requirements:

• Diploma in Engineering and related disciplines
• Strong data querying and analytical capabilities
• Proficient in English with strong verbal and written communication skills
• Able to perform effectively under pressure and meet deadlines
• Demonstrates strong resilience, adaptability, and positive work attitude

To submit your application, please apply online to apply@rn-care.com or call +65 6514 9838 for a private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd

EA License No: 17C8900

Responsibilities

• Lead and mentor a team of Test/Product Engineers in delivering technical solutions for yield improvement, device offload, and test program development/validation
• Oversee setup/hardware correlation and qualification activities
• Drive technical solutions for wafer sort and final test processes
• Spearhead system algorithm optimization and advanced analytics implementation
• Manage cross-functional project timelines with customers and internal stakeholders
• Chair Test/Product Engineering meetings and represent the team in customer discussions
• Lead continuous improvement initiatives for quality and productivity in Test Operations/QA
• Perform additional leadership duties as assigned

Requirements

• Degree in any engineering field
• Good communication and interpersonal skills
• At least 5 years relevant experience, preferably in a cleanroom environment
• Possess good project management, analytical and problem solving skills
• Ability and passion to work in and foster a teamwork environment
• Positive attitude with good communication and interpersonal skills

• Overall in charge for all site coordination relating to mechanical, electrical and plumbing (MEP) matters of the project. Overall responsible for all the MEP works installation and progress of work to meet contractual and specifications requirements.
• Leading in design coordination with consultants / client and authorities.
• Attend client, consultants and sub-con meetings.
• Review of shop drawings / materials / Method of Statements.
• To ensure drawing registry is maintained and latest drawings / BIM models are available for all parties involved (site staff, suppliers and subcontractors). To ensure transmittal forms / emails are issued for latest drawings / BIM models.
• Ensure that all the submittals are carried out timely and closely monitoring the progress and status.
• Resolve technical issues on drawings and liaise closely with all trades and authorities.
• Take lead in VDC for MEP related matters. Cross check BIM model with contract drawings and other disciplines, such as architectural, structural, etc.
• Review of contract documents and scope of works.
• Establish and implement quality control measures for MEP works after consulting with PM and Quality and Service Dept.
• To work with PM and Site Manager in planning and executing temporary works, in particular, the temporary services.
• To ensure all MEP submissions (as-built, COS etc) are done for RI (M&E) and TOP. To ensure that the project is ready for the RI and TOP inspections.
• Other ad-hoc duties as assigned by the immediate supervisor / management.

Job Requirements:

• Degree in Electrical Engineering /Mechanical Engineering /Building Service.
• Candidate with proficiency in BIM software such as Autodesk Revit will have added advantage.
• Minimum 5 years relevant experience in coordination and supervision of MEP works in local building construction. Preferably in high rise building projects.
• Good knowledge of MEP specifications, code of practices, standards and BCA quality requirements.

Key Responsibilities

• Design and develop sheet metal components using CAD tools (e.g. SolidWorks, AutoCAD)

• Prepare detailed engineering drawings, specifications, and technical documentation

• Select suitable materials based on design, manufacturability, and cost considerations

• Collaborate with production teams to ensure design feasibility and smooth execution

• Support new product introduction (NPI), including reverse engineering and product design

• Participate in quality assurance activities (e.g. inspection, testing, documentation)

• Work with sourcing, purchasing, sales, and suppliers to drive project progress

• Maintain engineering data (BOM, design changes) in systems such as PLM, SAP, MES

• Troubleshoot BOM and engineering data issues

• Manage multiple projects to meet timelines and deliverables

Requirements

• Diploma or Degree in Mechanical / Manufacturing Engineering or related field

• Minimum 7 years of experience in sheet metal fabrication

• Strong knowledge of sheet metal processes (bending, laser cutting, welding, etc.)

• Proficient in CAD/CAM tools (e.g. SolidWorks, AutoCAD)

• Familiar with sheet metal properties (mild steel, stainless steel, aluminium, copper)

• Strong analytical and problem-solving skills

• Able to interpret technical drawings and GD&T

• Experience with AMADA machines/software is an advantage

• Familiarity with Lean Manufacturing tools (e.g. Kaizen, VSM) is a plus

Summary
We are seeking a highly skilled Active Directory Engineer with experience in planning and executing Active Directory (AD) migrations/Upgrade. The ideal candidate will be responsible for developing comprehensive upgrade plans, performing assessments of existing environments, and ensuring a seamless migration with minimal disruption. In addition, candidate should have skill to lead the project and deal with stakeholders.

Responsibilities :

• Lead end-to-end Active Directory migration and upgrade initiatives across enterprise environments.
• Perform comprehensive assessments of existing AD infrastructure, including domain controllers, Group Policies, DNS, DFS, and security configurations.
• Design and implement AD upgrade strategies to modern Windows Server environments (e.g., Windows Server 2025).
• Identify and eliminate dependencies on legacy AD systems while ensuring business continuity.
• Plan and execute domain controller lifecycle activities, including promotion, demotion, and decommissioning.
• Collaborate with application, network, and security teams to ensure compatibility and seamless integration during migration.
• Work with application owners to remediate insecure protocols and remove hardcoded dependencies.
• Manage and troubleshoot Active Directory Federation Services (ADFS) and directory synchronization issues.
• Administer and support DFS, DNS, and Group Policy infrastructure.
• Utilize migration tools such as ADMT, Quest Migration Manager, or equivalent solutions.
• Develop and execute pre-migration validation, testing, and rollback strategies.
• Automate administrative and migration tasks using PowerShell scripting.
• Ensure adherence to security policies, compliance standards, and AD best practices.
• Provide post-migration support and resolve complex technical issues.
• Act as a technical lead, guiding L1/L2 engineers and ensuring adherence to ITIL processes.
• Prepare and maintain technical documentation, runbooks, and knowledge base articles.

Requirements

• Bachelor’s degree in Information Technology or related field
• Minimum 10 years of experience in Active Directory administration, engineering, and lifecycle management.
• Proven track record in planning and executing AD migration and upgrade projects.
• Strong expertise in multi-site, multi-domain, and multi-forest AD environments.
• Hands-on experience with AD migration tools (e.g., ADMT, Quest Migration Manager).
• Strong knowledge of Windows Server platforms (2016/2019/2022; 2025 preferred).
• Deep understanding of authentication, authorization, and OS-level security.
• Proficiency in PowerShell scripting for automation and administration.
• Experience with Active Directory Certificate Services (ADCS), ADFS, and Identity Management solutions.
• Knowledge of IAM, Entra ID, and Single Sign-On (SSO) technologies.
• Strong experience in DFS, DNS, and Group Policy management.
• Experience performing AD health checks and performance tuning.
• Familiarity with ITIL processes and tools such as ServiceNow (Incident, Problem, and Change Management).
• Strong problem-solving, troubleshooting, and analytical skills.
• Excellent communication, stakeholder management, and documentation skills.

Qualifications:

- 3-5 years working experience in C&S Engineering Consultancy Firm.

- Degree is recognized by Professional Engineers Board (PEB), Singapore.

- Preferably, has passed FEE, examination prescribed by PEB.

- Conversant with latest design codes and authority requirements.

- Competency in design software such as ETABS, SAFE, SAP2000, GSA, IDEA StatiCa, Tekla etc.

- Able to work independently to support the QP and directors.

- A team player and to carry out tasks/duties in a positive and dignified manner

Responsibilities:

- Responsible for the execution of civil and structural design involving the preparation of calculations, drawings and detailing.

- Assist in producing tender specifications and design requirements for calling of tender contracts.

- Attend project/technical meetings with authorities, developers and contractors.

- Involve in project planning, implementation and close monitoring of projects.

- Project coordination including submission to local authorities and liaison during the construction stage.

- Liaise with clients, consultants and authorities on technical matters.

Job Description 

• Monitor and manage the system to ensure that all system parameters are optimum. 
• Escalated to the necessary teams if there is any abnormality to the systems or the system parameters are less optimum. 
• Manage number of inbound and outbound calls in a timely manner 
• Follow communication “scripts” when handling different topics 
• Identify customers’ needs, clarify information, research every issue and provide solutions and/or alternatives 
• Build sustainable relationships and engage customers by taking the extra mile 
• Keep records of all conversations in our call center database in a comprehensible way 
• Collect, collate, compute and calculate the various support KPIs 
• Colate, computeand calculate the various system performance from system/application logs. 
• Other administrative tasks, documentation and creation reports to be assigned. 
• Conduct investigation activities to be assigned. 

JobRequirements 

• Diploma, Higher NITEC in Electrical, Electronics, IT or equivalent 
• Minimum 1 to 2 years of relevant experience 
• Relevant experience as a monitoring center engineer 
• Experience in electrical/mechanical drawing, service/repair manuals and or diagrams will be added advantage 
• Basic knowledge in Networking and Database management will be added advantage 
• Airport operations background will be added advantage 
• Strong communication and interpersonal skills. Self-starter, self-motivated and critical thinker who embraces challenges 
• Ability to work responsibly, independently and in a team 
• Able to interact with all levels of people and work under stress 
• Willing to work on a 12-hour rotational shift pattern, which includes day, night,weekends, public holidays etc. 
• Training will be provided 

Workinghours 

Rotating 12 hours shift or as assigned. 

4days 12 hours and 3 days rest 

Followed by 3 days 12 hours and 4 days rest

1. Strong communication, presentation skills in a dynamic and fast paced environment

2. Able to front users in gathering requirements, planning and exeuction

3. interest in learning and furthering agency and Gov interests in S&T, esp in sensors, autonomous equipment and Video analytics

4. Keen learner, and open to experiment beyond traditional technologies

5. Affinity with AI, coding and linking sensors to clouds and models will be an advantage.

Responsibilities:

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
• Perform collaborative work with the Compliance Engineering team on other CQV activities.
• Coordinate with both internal and external teams (manufacturing, engineering , quality, vendors, contractors, etc.) to achieve the site objectives.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements:

• Degree in Engineering/Science or related studies.
• Minimum of 3 years to 4 years of’ experience in relevant industry with at least 3 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
• Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
• Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
• Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
• Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS

Responsibilities:

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
• Perform collaborative work with the Compliance Engineering team on other CQV activities.
• Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements:

• Degree in Engineering/Science or related studies.
• Minimum of 4 years’ experience in relevant industry with at least 8 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
• Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
• Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
• Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
• Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS