QC Equipment Qualification Engineer

Key Responsibilities

• Qualification Lifecycle Management: Plan, draft, and execute full lifecycle validation documentation (DQ, IQ, OQ, PQ, URS, Traceability Matrices, and Validation Summary Reports) for QC laboratory instruments (e.g., HPLC, GC, UV-Vis, Dissolution Testers, pH Meters, Balances).
• Computerized Systems Compliance: Ensure analytical equipment controlling software (e.g., Empower, OpenLab, LIMS) complies with 21 CFR Part 11, EU Annex 11, and Data Integrity principles (ALCOA+).
• Risk Assessments & Compliance: Perform Quality Risk Assessments (FMEA / GAMP5) and gap assessments for existing and new laboratory computerized systems.
• Routine Compliance Activities: Execute Periodic System Reviews (PSR), Audit Trail reviews, User Access Management, and backup/restore verification for laboratory systems.
• Deviations & Change Control: Manage and investigate qualification deviations, non-conformances, and Out-of-Specification (OOS) events related to equipment qualification. Initiate and manage Change Control protocols for system upgrades or modifications.
• Cross-functional Collaboration: Work closely with QC Analysts, Quality Assurance (QA), IT, and external vendors to support site startup, instrument onboarding, and regulatory audit readiness.

About you

• Experience: 2 to 6+ years of hands-on experience in Equipment Qualification (CQV) and Computer System Validation (CSV) within a regulated pharmaceutical or biotech environment.
• Technical Expertise: Strong background in qualifying QC laboratory analytical instruments and familiarity with Chromatography Data Systems (CDS) like Empower, OpenLab, or LIMS.
• Regulatory Knowledge: Solid understanding of cGMP, GAMP5, Data Integrity (ALCOA+ principles), and 21 CFR Part 11 guidelines.
• Documentation Skills: Proven ability to independently write, execute, and review high-quality validation protocols, risk assessments, and technical summary reports.
• Soft Skills: Excellent analytical problem-solving skills, strong attention to detail, and the ability to work independently while managing cross-functional technical tasks.
• Education: Bachelor’s Degree in Chemical Engineering, Biotechnology, Chemistry, Pharmacy, Automation, or a related scientific/technical discipline.