Senior CQV Specialist

Piper Companies is seeking a Sr. CQV Specialist to support commissioning, qualification, and validation activities within a cutting-edge cell therapy manufacturing environment in Raritan, NJ . The Sr. CQV Specialist will play a critical role in ensuring compliant manufacturing processes, equipment qualification, and validation execution while supporting both clinical and commercial production in a highly regulated cGMP setting. 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. Compensation for the Sr. CQV Specialist includes: Pay Range: $50-$57 per hour (depending on experience), Comprehensive benefits package including medical, dental, vision, and retirement plans 6 Month Contract This job opens for applications on 08/31/2026. Applications for this job will be accepted for at least 30 days from the posting date. SEO Keywords Sr CQV Specialist, Commissioning Qualification Validation, CQV Engineer, Validation Specialist, Equipment Qualification, Process Validation, Requalification, cGMP, cGTP, Cell Therapy Manufacturing, CAR-T Manufacturing, Biotechnology, Pharmaceutical Validation, CAPA, Deviation Investigation, Risk Assessment, FMEA, Change Control, Validation Protocols, Validation Reports, Facility Qualification, Utility Qualification, Manufacturing Compliance, FDA Regulations, ICH Guidelines, Good Tissue Practices, Engineering Validation, Technical Operations, Quality Systems, Clinical Manufacturing, Commercial Manufacturing

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