Analytical / QC Laboratory Equipment CQV Engineer - #1167161

• Execute commissioning, qualification, and validation (IQ/OQ/PQ) of analytical and QC laboratory equipment.

• Prepare and review qualification documents including protocols, risk assessments, traceability matrices, deviations, CAPAs, and validation reports.

• Qualify laboratory equipment such as HPLC/UHPLC, GC, UV-Vis spectrophotometers, TOC analyzers, dissolution systems, balances, incubators, ovens, refrigerators, pH meters, conductivity meters, and related systems.

• Support FAT, SAT, calibration, installation verification, temperature mapping, and equipment handover.

• Verify computerized system controls and data integrity requirements including audit trails, user access, electronic signatures, backup/restore, and security.

• Support integration testing involving LIMS, chromatography data systems, MES, PCS, and historian platforms where applicable.

• Coordinate with QA, QC, Engineering, Automation, IT, vendors, and project stakeholders.

• Ensure all qualification documentation complies with GMP and Good Documentation Practices.

• Bachelor's Degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline.

• Minimum 5 years of CQV experience with analytical or QC laboratory equipment in pharmaceutical, biotechnology, or GMP-regulated environments.

• Strong knowledge of GMP, ALCOA+, equipment qualification lifecycle, and Good Documentation Practices.

• Experience preparing qualification protocols, deviations, risk assessments, and validation reports.

• Excellent technical writing, planning, and stakeholder management skills.

Preferred

• Experience with Empower, Chromeleon, LIMS, or other chromatography data systems.

• Knowledge of FDA, EU GMP, PIC/S, and laboratory computerized system validation.

• Experience supporting pharmaceutical manufacturing or biotechnology facilities.