Cqv Engineer - Analytical/QC Laboratory Equipment

ROLE OVERVIEW Responsible for the commissioning, qualification, and validation of analytical and QC laboratory equipment, ensuring compliance with GMP, regulatory requirements, and internal company procedures. Minimum 5 years of experience in qualification of analytical and QC laboratory equipment within pharmaceutical, biotechnology, or GMP-regulated environments. KEY RESPONSIBILITIES Develop and execute qualification protocols (IQ, OQ, PQ) Prepare and review qualification documents, risk assessments, and summary reports Perform commissioning and qualification of analytical/QC laboratory equipment, including: HPLC/UHPLC, GC, UV-Vis Spectrophotometers, TOC Analyzers, Dissolution Systems, pH & Conductivity Meters, Balances, Laboratory Incubators, Ovens, and Refrigerators Support FAT, SAT, calibration, and vendor management activities Perform temperature mapping Manage deviations, CAPAs, and change controls Coordinate with QA, QC, Engineering, and Vendors to ensure timely qualification completion Execute and document IQ, OQ, PQ, and FAT/SAT support activities Manage deviations and discrepancy resolution Ensure complete traceability from URS through testing Verify data integrity and cybersecurity elements including audit trails, user account management, security roles, electronic signatures, backup and restore functionality, and time synchronization Support integration with LIMS, CDS, PCS, MES, and OSI PI Historian Coordinate with Automation, CQV, Quality, IT, and Manufacturing teams Review vendor documentation and test evidence REQUIRED QUALIFICATIONS Bachelor's Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or related field Minimum 5 years of CQV experience for analytical/QC laboratory equipment Good understanding of GMP, Data Integrity (ALCOA+), and qualification lifecycle requirements DESIRABLE Experience in pharmaceutical or biotechnology manufacturing facilities Familiarity with chromatography data systems (e.g. Empower, Chromeleon) and CSV requirements Knowledge of regulatory requirements including FDA, EU GMP, and PIC/S guidelines