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 09/14/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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