Senior CQV Specialist

Responsibilities: of the Sr. CQV Specialist: • Execute commissioning, qualification, requalification, and validation activities for manufacturing equipment, utilities, facilities, and systems supporting cell therapy production. • Write, review, and execute CQV protocols, summary reports, risk assessments, change controls, and related documentation while ensuring data integrity and regulatory compliance. • Lead technical investigations, deviations, CAPAs, remediation efforts, and corrective actions associated with CQV activities. • Collaborate cross-functionally with Manufacturing, Engineering, Quality, and external vendors to drive validation projects through successful completion. • Support regulatory inspections and internal audits by presenting validation strategies, documentation, and program outcomes. • Mentor junior team members and provide guidance on qualification programs, documentation development, and validation best practices. Qualifications: of the Sr. CQV Specialist: • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. • 8+ years of CQV, validation, commissioning, or qualification experience within a cGMP-regulated pharmaceutical, biotechnology, or cell therapy environment. • Strong equipment qualification experience with the ability to independently execute validation activities and lead projects from initiation through completion. • Experience authoring and executing validation documentation including protocols, reports, SOPs, work instructions, risk assessments, and change controls. • Working knowledge of cGMP, cGTP, ICH guidelines, and 21 CFR Parts 210, 211, and 1271; experience with CAR-T or cell therapy manufacturing is highly preferred.