Description:
The CSV Engineer / Specialist will support validation activities for GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. This is a hands-on role focused on executing CSV lifecycle deliverables in close collaboration with Quality, Engineering, IT, and project teams to ensure regulatory compliance and on-time project delivery.
Key Responsibilities
- Execute end-to-end CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipment
- Prepare, review, and support approval of validation documentation, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, and Validation Reports
- Apply risk-based validation approaches for new and existing systems in line with GAMP 5 principles
- Ensure CSV activities comply with cGMP, GAMP 5, EU Annex 11, and 21 CFR Part 11 requirements
- Partner with project teams to align validation deliverables with project schedules and milestones
- Participate in validation risk assessments to define appropriate testing scope and strategy
- Review system specifications, design documentation, installation records, and qualification evidence
- Support validation activities across manufacturing, packaging, and laboratory computerized systems
- Raise, track, and support closure of validation deviations, discrepancies, and observations
- Support investigations and assess data integrity risks during validation and routine operations
- Perform periodic reviews of computerized systems and support identification of compliance gaps
- Contribute to the development, review, and maintenance of CSV and qualification SOPs
- Support regulatory inspections and internal audits as required
- Collaborate with local and global CSV teams to ensure consistent validation execution
- Escalate potential quality or compliance risks to senior CSV or Quality leadership
- Adhere to site EHS and safety procedures during commissioning and validation activities
Qualifications & Experience
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline
- 4–7 years’ experience in Computer System Validation within a regulated pharmaceutical or biopharmaceutical environment
- Strong understanding of CSV regulations, industry standards, and quality expectations
- Hands-on experience validating GAMP Category 3, 4, and 5 systems
- Proven experience executing validation protocols and managing CSV documentation
- Working knowledge of EU Annex 11, 21 CFR Part 11, and GAMP guidelines
- Experience supporting investigations, root cause analysis, and CAPA activities
- Strong documentation skills with the ability to collaborate effectively across cross-functional teams