As a CQV Engineer, you will be responsible for commissioning, qualification, and validation activities for analytical and QC laboratory equipment, ensuring compliance with GMP requirements, regulatory standards, and internal procedures.
Key responsibilities include:
Develop and execute qualification protocols including IQ, OQ, and PQ.
Perform commissioning and qualification activities for analytical/QC laboratory equipment, including:
HPLC / UHPLC
Gas Chromatography (GC)
UV-Vis Spectrophotometers
TOC Analysers
Dissolution Systems
pH & Conductivity Meters
Balances
Laboratory Incubators, Ovens, and Refrigerators
Prepare and review qualification documents, risk assessments, and validation summary reports.
Support FAT (Factory Acceptance Test), SAT (Site Acceptance Test), calibration, and vendor management activities.
Perform temperature mapping activities.
Manage deviations, CAPAs, and change controls throughout the qualification lifecycle.
Ensure traceability from User Requirement Specifications (URS) through qualification testing.
Support integration and verification of laboratory systems including LIMS, CDS, PCS, MES, and OSI PI Historian.
Verify data integrity requirements including:
Audit trails
User access management
Security roles
Electronic signatures
Backup and restore functionality
Time synchronisation
Collaborate with QA, QC, Engineering, Automation, IT teams, and external vendors to ensure timely project completion.
