About this opportunity
Piper Companies lists this Sr. CQV Specialist - 174084 - 1747 opportunity in raritan, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a leading cell therapy manufacturing organization in Raritan, NJ. The Sr CQV Specialist will play a key role in maintaining compliant manufacturing operations, supporting audits and investigations, and mentoring junior engineers in a fast-paced environment where each batch directly impacts a patient.
Responsibilities of the Sr CQV Specialist
Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and processes
Author and execute CQV protocols, reports, and associated documentation ensuring compliance and data integrity
Lead or support deviations, investigations, CAPAs, corrections, and remediation efforts
Manage multiple CQV projects while collaborating with cross-functional teams and vendors
Support change controls, risk assessments, FMEAs, periodic reviews, and validation lifecycle activities
Present CQV activities during regulatory inspections and internal audits
Train and mentor junior team members on CQV processes and best practices
Qualifications of the Sr CQV Specialist
Bachelor’s degree in Science, Engineering, or a related technical discipline
8+ years of CQV experience within pharmaceutical, biotech, biologics, or cell therapy manufacturing environments
Strong knowledge of cGMP, cGTP, FDA/EU regulations, and validation lifecycle principles
Experience with investigations, CAPAs, change controls, and remediation activities
Familiarity with Kneat, Maximo, Siemens EMS, Comet, Kaye AVS, and Kaye ValProbe preferred
Ability to work independently, manage shifting priorities, and mentor junior engineers
Strong communication skills with experience supporting audits and inspections
Compensation for the Sr CQV Specialist includes
Salary range: $55-60/hr
6-month contract opportunity with the potential for extension
Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave (as required by law), and Paid Holidays
This job opens for applications on 10/05/2026. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: CQV, Commissioning, Qualification, Validation, cGMP, cGTP, Cell Therapy, CAR-T, Deviations, CAPA, Change Control, Risk Assessments, FMEA, Data Integrity, Validation Protocols, SOPs, Regulatory Audits, FDA, ICH, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 1271, Kneat, Maximo, Kaye AVS, Kaye ValProbe
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.