We are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment.
The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while supporting continuous improvement initiatives.
Key Responsibilities
- Perform validation of QC systems such as LIMS, Empower, CDS, and other analytical equipment.
- Author and execute CSV deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, Summary Reports).
- Manage system lifecycle activities, including change controls, periodic reviews, and data integrity assessments.
- Ensure audit and inspection readiness for CSV documentation.
- Contribute to error-reduction and continuous improvement activities within QC operations.
Requirements
- 5 years' experience in CSV within the pharmaceutical or biotechnology industry.
- Hands-on experience with laboratory systems validation.
- Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.
- Experience supporting audits and regulatory inspections.
- Strong documentation and stakeholder collaboration skills.