Senior CQV Specialist — Cell Therapy Validation Leader

Piper Companies; Raritan (NJ); Sur place; USD 157 597 000 - 171 924 000; Plein temps

Avantages offerts par ce poste

Medical

Dental

Vision

401K

PTO

Sick Leave

Paid Holidays

Résumé du poste

Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a leading cell therapy manufacturer in Raritan, NJ. You will drive CQV deliverables, ensure data integrity, and partner with cross-functional teams during audits and inspections.

The role requires 8+ years in CQV within pharma/biotech/cell therapy, strong cGMP knowledge, and the ability to mentor junior engineers.

Qualifications

• 8+ years CQV experience in pharmaceutical, biotech, biologics, or cell therapy environments.
• Strong knowledge of cGMP, cGTP, FDA/EU regulations and validation lifecycle principles.
• Experience with investigations, CAPAs, change controls, and remediation activities.
• Mentor junior engineers and support audits/inspections.
• Proficiency with CQV documentation and protocols.

Responsabilités

• 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.

Connaissances

CQV experience

cGMP knowledge

Regulatory inspections

Mentoring

Documentation

Formation

Bachelor’s degree

Outils

Kneat

Maximo

Siemens EMS

Comet

Kaye AVS

Kaye ValProbe

Description du poste

Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a leading cell therapy manufacturer in Raritan, NJ. You will drive CQV deliverables, ensure data integrity, and partner with cross-functional teams during audits and inspections.

The role requires 8+ years in CQV within pharma/biotech/cell therapy, strong cGMP knowledge, and the ability to mentor junior engineers.