CQV Engineer - Lab Equipment

The CQV Engineer – Lab Equipment is responsible for the Commissioning, Qualification, and Validation (CQV) of laboratory instruments and systems. This role ensures all lab equipment is commissioned, qualified, and validated according to current regulatory standards (GMP, GLP) and internal quality expectations. The CQV Engineer will plan, execute, and document the full CQV lifecycle for new and existing lab equipment, collaborating closely with cross-functional teams, vendors, and project stakeholders to maintain a compliance-driven laboratory environment.

• Take ownership of commissioning, qualification, and validation activities for laboratory equipment, from protocol development to execution and closure (FAT, SAT, IQ, OQ, PQ).
• Develop and maintain CQV documentation, including validation master plans, risk assessments, protocols, traceability matrices, final reports, and SOPs.
• Oversee and perform commissioning tasks to ensure new and upgraded lab equipment is correctly installed and operational, meeting all utility and safety requirements.
• Lead qualification and validation processes to verify lab equipment consistently operates and performs as intended, according to user and functional specifications.
• Drive investigation and resolution of deviations or non-conformances identified during CQV execution, ensuring proper root cause analysis and corrective actions.
• Execute, review, and approve change control and requalification efforts for lab equipment.
• Coordinate with vendors for CQV test support, technical documentation, training, and troubleshooting of technical issues.
• Work closely with Quality Assurance, QA Validation, Laboratory, and IT teams to ensure compliance with GMP, data integrity, computerized system validation (CSV), and 21 CFR Part 11 requirements.
• Maintain complete, accurate, and audit-ready documentation of all CQV activities as per regulatory and company policies.
• Provide expertise and training to laboratory users on equipment qualification status, maintenance, and compliance requirements.
• Support continuous improvement initiatives for CQV processes and lab equipment lifecycle management.

• Bachelor’s degree (or higher) in Engineering, Life Sciences, or related field.
• Minimum 5 years of hands-on experience performing commissioning, qualification, and validation (CQV) of lab equipment in regulated environments (pharmaceutical, biotechnology, analytical laboratories, etc.).
• Expert understanding of GMP/GxP regulations, lab equipment qualification, and the complete CQV lifecycle.
• Practical experience authoring and executing CQV protocols (FAT, SAT, IQ, OQ, PQ) for a broad range of laboratory tools and systems.
• Strong technical writing and documentation skills, with the ability to produce clear, accurate, and compliant CQV records. xcfaprz
• Excellent organizational, communication, and cross-functional collaboration skills.
• Experience with computerized system validation (CSV) and regulatory requirements for lab instrument software is preferred