We are seeking an experienced CSV Engineer to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with 21 CFR Part 11, Annex 11, GAMP 5, and collaborating with cross-functional teams for successful project delivery.
Key Responsibilities
- Develop and execute validation plans, test plans, and qualification protocols (IQ, OQ, PQ, PPQ) for lab, manufacturing, and automation systems.
- Perform CSV deliverables including URS, risk assessments, traceability, and test scripts.
- Ensure compliance with data integrity (ALCOA+), 21 CFR Part 11, and GMP guidelines.
- Manage change control, deviations, CAPA, and risk assessments (pFMEA/dFMEA).
- Coordinate with QA, QC, IT, and Engineering for validation activities and project timelines.
- Maintain accurate documentation for audits and regulatory inspections.
- Apply GAMP 5, V-Model, and Agile methodologies in validation lifecycle.
Qualifications & Skills
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
- 3-6 years experience in CSV within pharma/biotech/life sciences.
- Strong knowledge of validation protocols (IQ/OQ/PQ/PPQ), data integrity, audit trails, and compliance standards.
- Exposure to Automation, DeltaV, PLCs, or MES systems will be a strong advantage.
- Hands-on with lab/analytical systems, LIMS, or automation control systems preferred.
- Excellent problem-solving and documentation management skills.
