QA CSV Engineer

Role Overview:

We are looking for an experienced QA CSV Engineer to support Computer System Validation (CSV) activities in alignment with cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and other industry standards for a critical pharmaceutical project. This role will be pivotal in providing quality oversight, managing validation deliverables, and ensuring compliance with data integrity principles, including ALCOA+. The ideal candidate will be responsible for overseeing validation protocols (IQ/OQ/PQ), supporting system upgrades, and collaborating with cross-functional teams on new system implementations.

Key Responsibilities:

1. Quality Oversight & Compliance:

• Provide QA oversight for CSV activities, ensuring alignment with cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and company quality policies.

• Ensure all project activities adhere to data integrity principles, including ALCOA+ requirements.

• Review and approve validation deliverables including:

  • User Requirements Specifications (URS)

  • Functional Specifications (FS)

  • Risk assessments

  • IQ/OQ/PQ protocols and reports

  • Test deviations, incidents, and change controls

• Ensure all documentation is audit-ready, complete, clear, and compliant with regulatory standards.

2. Project Team Participation:

• Act as the QA representative on project teams for system upgrades, replacements, and new system implementations.

• Ensure project schedules account for appropriate QA activities, validation timelines, and regulatory requirements.

• Proactively identify quality and compliance risks early in the project lifecycle and escalate issues to the Department Manager as needed.

3. Stakeholder Collaboration:

• Work closely with cross-functional teams, including IT, OT, Validation, Engineering, and User departments, to ensure systems are fit for intended use and compliant throughout their lifecycle.

• Act as a problem solver to help teams interpret requirements, mitigate compliance gaps, and maintain project momentum.

• Provide QA input during project meetings, design reviews, FAT/SAT, and qualification activities.

4. Documentation & Change Management:

• Review and approve change controls related to computerized systems and validation processes.

• Ensure all documentation is complete, clear, and audit-ready at every stage of the project lifecycle.

• Support the Department Manager with high-risk decisions, validation strategies, and validation plans to ensure compliance and successful project delivery.

Key Requirements:

Experience:

• 5+ years of experience in QA/CSV within pharmaceutical, biopharma, or regulated manufacturing environments.

• Strong experience with system validation including IQ/OQ/PQ, URS, FS, and change control activities.

• Familiarity with GAMP 5, 21 CFR Part 11, Annex 11, and cGMP standards.

• Proven ability to collaborate with cross-functional teams, including IT, OT, Engineering, and Validation.

• Experience with FAT/SAT, risk assessments, and managing change control activities.

Technical Skills:

• Strong knowledge of computerized systems used in regulated environments.

• Expertise in validation documentation (URS, FS, IQ/OQ/PQ protocols, and reports).

• Familiarity with data integrity principles and ALCOA+ requirements.