
CSV Engineer – QC Systems
1 week ago
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.
- 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.
Quality Control and Assurance
Pharmaceutical Manufacturing
Quality Assurance
GMP
GAMP
Traceability
Biotechnology
Computer System Validation
LIMS
Audits
Pharmaceutical industry experience
Pharmaceutical Engineering
Laboratory
Biopharmaceuticals
Audit
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