We are looking for a QC Engineer to support validation of analytical laboratory instruments and computerized systems in a GMP-regulated environment. The role focuses on ensuring compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.
Key Responsibilities
- Plan, execute, and document qualification/validation of analytical instruments (e.g., HPLC, GC, UV, CDS, LIMS, Empower).
- Prepare, review, and execute CSV deliverables such as URS, IQ/OQ/PQ, RTM, and summary reports.
- Perform data integrity assessments and ensure compliance with ALCOA+, GDP, and cGMP guidelines.
- Draft, review, and maintain validation-related SOPs for QC systems and equipment.
- Support audits and inspections with accurate validation documentation.
- Collaborate with QC, QA, and IT to ensure readiness for system lifecycle activities (periodic review, change control, upgrades, cyber-resilience).
- Contribute to continuous improvement initiatives to strengthen QC lab compliance.
Requirements
- Bachelor's degree or higher in Chemistry, Life Sciences, Engineering, or related field.
- 5-10 years experience in CSV/validation of analytical instruments within QC labs in pharmaceutical/biotech.
- Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity frameworks.
- Experience with microbiology analytical equipment is an advantage.
- Hands-on use of Kneat or other e-validation platforms preferred.
- Strong technical documentation and troubleshooting skills.
- Able to work cross-functionally and support audit readiness.
