Sr. CQV Specialist – Cell Therapy Manufacturing

Job DescriptionWe are seeking an experienced Sr. CQV Specialist to support Commissioning, Qualification, and Validation (CQV) activities within a cGMP Clinical and Commercial Cell Therapy Manufacturing environment. This role will be responsible for executing and managing CQV activities related to facilities, utilities, equipment, systems, and manufacturing processes supporting personalized cell therapy production. The ideal candidate will have strong experience in aseptic manufacturing environments, excellent knowledge of cGMP regulations, and the ability to independently manage complex validation projects while collaborating with cross-functional teams.Key SkillsCommissioning, Qualification & Validation (CQV), cGMP and cGTP Compliance, Change Controls, Deviations, CAPAs, Risk AssessmentsValidation Lifecycle Documentation, Equipment Qualification, Facility Validation, Data Integrity, GDP PracticesAseptic Manufacturing, Cell Therapy Manufacturing, Biologics Manufacturing, Sterile Manufacturing OperationsMaximo, Siemens EMS, Comet, Kneat, Kaye AVS, Kaye ValProbeRequired QualificationsBachelor’s Degree in Engineering, Science, or related technical discipline required8+ years of relevant CQV/Validation experience within pharmaceutical, biotech, medical device, or cell therapy industriesStrong experience in aseptic manufacturing and cGMP-regulated environments preferredExperience supporting cell therapy, biologics, or sterile manufacturing operations is highly preferredExperience executing CQV activities, authoring validation documentation, supporting deviations, CAPAs, change controls, audits, inspections, and validation lifecycle managementStrong understanding of FDA and EU cGMP regulations, cGTP, 21 CFR Parts 210, 211, and 1271, ICH guidelines, and validation compliance standardsAdditional SkillsStrong written and verbal communication skillsAbility to manage multiple priorities independentlyExcellent troubleshooting and problem-solving abilitiesExperience presenting during audits and inspectionsAbility to work effectively in cross-functional team environments