Senior Specialist

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

#LI-CK1 #LI-ONSITE