QA CSV Engineer
Date Posted: February 6, 2026
Job Description
Quality Governance: Provide independent QA oversight for CSV activities, ensuring all project milestones align with global regulatory standards and internal quality policies.
Validation Lifecycle Management: Review and approve critical deliverables, including URS, FS, Risk Assessments, and IQ/OQ/PQ protocols and reports.
Project Leadership: Act as the QA representative in cross-functional project squads (IT, OT, Engineering, and Validation) for system upgrades and new greenfield/brownfield implementations.
Risk & Change Management: Manage the review of test deviations, incidents, and change controls. Proactively identify compliance gaps early in the project lifecycle to mitigate deployment risks.
Regulatory Readiness: Ensure all CSV documentation is “Audit Ready” at every stage, providing expert input during FAT/SAT and qualification phases.
Key Responsibilities
5+ years of dedicated QA/CSV experience within the pharmaceutical or biopharma sector.
Deep mastery of GAMP 5, 21 CFR Part 11, and EudraLex Annex 11.
Hands-on experience with Data Integrity principles (ALCOA+) and their practical application in automated manufacturing.
Proven ability to manage cross-functional stakeholders (Engineering vs. IT vs. Production).
Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
Required Qualifications and Skills
- Degree in Mechanical or Electrical Engineering
- 10+ years’ experience managing MEP works
- Strong leadership and coordination skills
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