Lab CQV Specialist

Responsibilities

• Lead and execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for QC laboratory equipment in accordance with approved protocols and regulatory expectations.
• Develop, review, and approve qualification documentation, including validation plans, risk assessments, protocols, and final reports for QC instruments and systems.
• Perform commissioning and decommissioning activities for laboratory instruments, ensuring proper documentation, adherence to change control processes, and alignment with lifecycle management strategies.
• Carefully coordinate and support the installation, relocation, and startup of new and existing QC laboratory equipment, including planning and oversight of on-site activities.
• Manage equipment lifecycle events such as upgrades, replacements, retirements, and obsolescence planning to ensure continuity of laboratory operations.
• Interface with external vendors during factory acceptance testing (FAT), site acceptance testing (SAT), installation, qualification, and service activities.
• Support qualification and validation of laboratory utilities and systems such as purified water and WFI systems, water testing equipment, and environmental monitoring systems.
• Qualify and maintain particle counters, temperature-controlled units (incubators, ovens, refrigerators, freezers), and other critical QC laboratory equipment.
• Ensure all qualification, validation, and lifecycle activities comply with cGMP, FDA, ICH, USP, EU Annex 11, and applicable data integrity requirements.
• Initiate and support deviations, investigations, corrective and preventive actions (CAPAs), and change controls related to laboratory equipment and systems.
• Provide technical guidance and training to QC laboratory staff on equipment use, qualification status, and documentation expectations.
• Partner with QC analysts, QA, Engineering, Metrology, and IT to ensure successful equipment qualification, ongoing compliance, and timely resolution of issues.
• Support laboratory expansions, technology transfers, and continuous improvement initiatives by providing CQV expertise and project support.
• Contribute to the establishment and validation of a brand new microbiology laboratory while also supporting four existing laboratories on site.

Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline, or equivalent experience.
• 3–7+ years of experience in commissioning, qualification, and validation (CQV), equipment qualification, or validation within a pharmaceutical, biotechnology, or regulated laboratory environment.
• Demonstrated experience qualifying QC laboratory equipment, including analytical instruments and laboratory systems, in a GMP environment.
• Hands-on experience with IQ/OQ/PQ execution and documentation for laboratory instruments and utilities.
• Installation Qualification experience, with a minimum of 5–8 years installing and qualifying new laboratory equipment such as HPLC systems, balances, water systems, and particle counters.
• Strong understanding of cGMP regulations, data integrity principles, and regulatory expectations for laboratory equipment and computerized systems.
• Experience with change control systems, deviation management, and CAPA processes in a regulated environment.
• Familiarity with electronic systems such as LIMS, CMMS, validation management systems, and document management systems.
• Experience with computer systems validation (CSV) for laboratory-related systems.
• Excellent technical writing skills for authoring and reviewing validation protocols, reports, and SOPs.
• Strong organizational skills with the ability to manage multiple concurrent qualification and validation activities.
• Educational background in chemistry, biology, engineering, or a related scientific field.

Skills

• Strong understanding of cGMP regulations, data integrity principles, and regulatory expectations for laboratory equipment and computerized systems.
• Experience with change control systems, deviation management, and CAPA processes in a regulated environment.
• Familiarity with electronic systems such as LIMS, CMMS, validation management systems, and document management systems.
• Experience with computer systems validation (CSV) for laboratory-related systems.
• Excellent technical writing skills for authoring and reviewing validation protocols, reports, and SOPs.
• Strong organizational skills with the ability to manage multiple concurrent qualification and validation activities.