Lab CQV Specialist

Lab CQV Specialist

The QC Laboratory Equipment Qualification & Validation Specialist manages the full lifecycle of quality control laboratory equipment in a GMP-regulated pharmaceutical environment. This role leads the installation, commissioning, qualification, decommissioning, and re-commissioning of analytical and support equipment, ensuring that all instruments and systems remain qualified, maintained, and compliant with regulatory requirements, internal procedures, and data integrity standards. The specialist works closely with cross-functional teams to support laboratory readiness, inspection preparedness, and continuous improvement across both new and existing QC laboratories.

• 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.
• Support re-qualification and periodic review of existing laboratory equipment to maintain a validated state throughout its lifecycle.
• 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.
• Provide qualification and validation support for analytical instruments including HPLC/UPLC systems, balances, pH meters, spectroscopic systems, and dissolution equipment.
• 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.
• Author, review, and revise standard operating procedures (SOPs), work instructions, and validation templates that govern equipment management and qualification processes.
• Maintain audit-ready documentation and actively support internal, client, and regulatory inspections by providing technical and documentation support.
• Partner with QC analysts, QA, Engineering, Metrology, and IT to ensure successful equipment qualification, ongoing compliance, and timely resolution of issues.
• Provide technical guidance and training to QC laboratory staff on equipment use, qualification status, and documentation expectations.
• Support laboratory expansions, technology transfers, and continuous improvement initiatives by providing CQV expertise and project support.
• Act as a project lead or project manager for new lab validation and systems validation, identifying gaps, developing remediation plans, and driving execution to close gaps.
• Contribute to the establishment and validation of a brand new microbiology laboratory while also supporting four existing laboratories on site.

• 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,…