QA CSV Engineer
Date Posted: February 6, 2026
Job Description
The QA CSV Engineer provides critical quality oversight for Computer System Validation (CSV) activities within a regulated pharmaceutical environment. In this role, you drive compliance with cGMP, GAMP 5, and global industry standards while managing the validation of complex systems for high-priority projects. You ensure that every stage of the system lifecycle upholds strict data integrity principles, including ALCOA+, to keep the facility inspection-ready at all times.
Key Responsibilities
- Drive Quality Oversight by ensuring all CSV activities align with cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 requirements.
- Review and Approve essential validation deliverables, including User Requirements Specifications (URS), Functional Specifications (FS), and Risk Assessments.
- Oversee Protocol Execution by authorizing IQ/OQ/PQ protocols and reports while managing test deviations, incidents, and change controls.
- Champion Data Integrity across the project lifecycle to ensure all computerized systems meet ALCOA+ standards.
- Serve as the QA Representative on project teams for system upgrades, replacements, and new implementations.
- Proactively Identify Risks early in the project lifecycle and escalate compliance gaps to the Department Manager to ensure timely resolution.
- Partner with Cross-Functional Teams, including IT, OT, Engineering, and Validation, to verify that systems remain fit for their intended use.
- Provide Expert Input during high-impact project milestones such as design reviews, FAT/SAT, and qualification activities.
- Manage Documentation Flow to ensure all records remain complete, clear, and audit-ready for regulatory inspections.
Required Qualifications and Skills
- 5+ years of experience in QA/CSV within a pharmaceutical, biopharma, or regulated manufacturing environment.
- Deep understanding of computerized system validation, including IQ/OQ/PQ, URS, and FS development.
- Demonstrate a strong working knowledge of GAMP 5, 21 CFR Part 11, and Annex 11 standards.
- Proven experience managing FAT/SAT, risk assessments, and complex change control activities.
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Communicate effectively with diverse departments to interpret requirements and maintain project momentum.
- Strong analytical skills to mitigate compliance gaps and resolve technical challenges.
- Hold a specialised certifications in CSV, GAMP 5, or 21 CFR Part 11.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E