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