CQV Specialist

Responsibilities: of the CQV Specialist: • Lead commissioning and qualification activities for new QC lab equipment, with a primary focus on TCU equipment and associated lab systems. • Develop, execute, and document IQ/OQ/PQ protocols to ensure equipment meets regulatory, quality, and operational requirements. • Perform method qualification and validation activities on newly installed lab instrumentation and support validation lifecycle documentation. • Support lab software upgrades and change control activities while maintaining equipment in a validated state. • Coordinate decommissioning activities for legacy lab equipment, ensuring proper documentation, compliance, and asset retirement processes. Qualifications: of the CQV Specialist: • 5+ years of experience supporting CQV, validation, or qualification activities within a GMP-regulated pharmaceutical or biotechnology environment. • Hands-on experience developing and executing commissioning, IQ/OQ/PQ, and equipment qualification protocols. • Strong understanding of FDA regulations, GMP requirements, data integrity principles, and validation lifecycle practices. • Experience supporting lab instrumentation, analytical equipment, computerized systems, and software validation activities.