CQV Engineer is responsible for executing commissioning, qualification, and validation activities for laboratory equipment within pharmaceutical or biotechnology facilities. This role focuses on systems such as HPLCs, incubators, centrifuges, autoclaves, analytical instruments, and various lab support equipment. The CQV Engineer collaborates with project and validation teams to ensure all equipment meets regulatory standards and is audit-ready.Key ResponsibilitiesPerform commissioning, qualification, and validation (CQV) for laboratory equipment, including but not limited to HPLCs, analytical balances, incubators, centrifuges, autoclaves, and washers.Prepare, execute, and review DQ/IQ/OQ/PQ protocols, validation plans, and reports, ensuring full regulatory compliance.Support installation, calibration, and functional testing of laboratory equipment.Collaborate with project engineers, QA, laboratory users, and vendors to resolve technical issues and deliver documentation.Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and troubleshooting during project phases.Maintain up-to-date and audit-ready documentation, including equipment manuals, calibration records, and protocol/reports.Identify, escalate, and assist in resolving deviations, non-conformities, and changes during CQV execution.Ensure all work follows cGMP, FDA, EudraLex, and internal SOPs.Assist with technical training and knowledge transfer for operators and maintenance staff.Contribute to continuous improvement in CQV processes and methodologies.Qualifications & ExperienceBachelor’s degree in Engineering, Life Sciences, or related technical field.4+ years of CQV experience in pharmaceutical, biotech, or laboratory environments.Direct hands-on experience with commissioning and qualification of laboratory equipment (HPLC, balances, incubators, etc.).Knowledge of validation lifecycle, GMP requirements, and quality systems.Familiarity with standard laboratory practices and regulatory guidelines.Strong troubleshooting, documentation, and communication skills.
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