CQV Engineer - Labs

Role Overview:

The CQV (Commissioning, Qualification, and Validation) Engineer for Lab Equipment is responsible for planning, coordinating, and executing CQV activities associated with laboratory equipment in a pharmaceutical manufacturing or QC laboratory environment. The role ensures that all lab assets are fully qualified, compliant with regulatory standards, and fit for purpose within a cGMP framework. The engineer will utilize electronic validation platforms such as Kneat to efficiently manage documentation and workflow.

Key Responsibilities:

• Lead and/or support the commissioning, qualification (IQ/OQ/PQ), and validation of laboratory equipment such as HPLCs, UPLCs, GCs, balances, incubators, centrifuges, autoclaves, environmental chambers, and other analytical systems.
• Develop, review, and execute validation protocols, risk assessments, supporting technical documentation, deliverables, and final reports using Kneat or similar electronic validation systems; ensure alignment with cGMP and internal quality systems.
• Manage the end-to-end CQV documentation lifecycle (creation, routing, approval, storage, retrieval) within Kneat, maintaining data integrity and audit readiness.
• Coordinate with equipment vendors, contractors, quality assurance, lab users, and other stakeholders during the project lifecycle, including FAT, SAT, installation, qualification, and troubleshooting.
• Review and assess equipment design, installation, and system suitability as part of the qualification process.
• Execute and document commissioning and qualification test scripts, investigate deviations, and support non-conformance resolution, all within Kneat.
• Ensure all instruments and equipment are correctly calibrated, maintained, and compliant through their lifecycle.
• Maintain and update equipment validation master plans, project schedules, status trackers, and equipment lists utilizing Kneat where applicable.
• Participate in project planning and design reviews, providing CQV input for new equipment or lab upgrades.
• Serve as CQV SME (Subject Matter Expert) for lab equipment and electronic validation tools during regulatory inspections and audits.
• Propose and implement process improvements related to equipment qualification, data integrity, and regulatory compliance.
• Ensure compliance with relevant regulations, such as FDA, EMA, and other regional/international guidance.
• Support Data Integrity and ALCOA+ principles, focusing on system controls and record-keeping via Kneat.

Key Requirements:

• Bachelor’s degree or higher in Engineering, Sciences, or a closely related discipline.
• Minimum of 5 years’ CQV/Validation experience in the pharmaceutical or biotechnology industry, with a significant focus on laboratory equipment.
• Extensive working knowledge of GMP, GAMP, ICH, USP, data integrity requirements, and relevant regulatory guidelines for laboratory systems.
• Demonstrable experience working with Kneat or similar electronic quality/document management systems for validation lifecycle management.
• Proven experience developing and executing IQ/OQ/PQ protocols and managing deviations and change controls, ideally leveraging an electronic system such as Kneat.
• Strong understanding of laboratory workflows, analytical technologies, and system interfaces (including computerized systems).