Key Skills

Job Description

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).

Core Responsibilities

Plan and execute commissioning, qualification, and validation activities for laboratory equipment, including protocols, testing, documentation, calibration, and lifecycle management using Kneat or similar systems. Coordinate with vendors, quality teams, and laboratory stakeholders, resolve deviations, support audits, and ensure compliance with cGMP, regulatory requirements, and data integrity principles.

Requirements

Requires a bachelor’s degree or higher in engineering, science, or a related discipline, and at least five years of pharmaceutical or biotechnology CQV/validation experience with a focus on laboratory equipment. Candidates should have strong knowledge of GMP, GAMP, ICH, USP, data integrity, IQ/OQ/PQ execution, deviation and change control, and experience with Kneat or a similar electronic system.