We are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.
Key Responsibilities
- Lead CSV activities for analytical equipment or instruments and lab computerized systems (e.g., HPLC, GC, UV, LIMS, Empower).
- Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ, RTM, and summary reports.
- Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity controls.
- Evaluate and validate audit trails, security settings, and user access controls.
- Support integration between instrument, PC, network, and enterprise systems.
- Draft, review, and maintain SOPs, validation documentation, and audit readiness materials.
- Contribute to lifecycle management of systems including periodic reviews, upgrades, and change control.
- Collaborate with QA, QC, and IT to support inspection readiness and continuous improvement.
Requirements
- Bachelor's degree in chemistry, Life Sciences, Engineering, or related discipline.
- 3-10 years experience in analytical instrument/equipment CSV within pharmaceutical/biotech QC labs.
- Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11.
- Hands-on experience with microbiology analytical equipment is an advantage.
- Familiarity with electronic validation tools (e.g., Kneat) is preferred.
- Strong documentation, troubleshooting, and cross-functional collaboration skills.
