Senior CQV Specialist - Cell Therapy Validation Lead

Piper Companies; Raritan (NJ); On-site; USD 76,000 - 83,000; Part time

Benefits offered by this job

Medical, Dental, Vision

401K

PTO & Paid Holidays

Onsite Work

Job summary

Piper Companies is seeking a Sr CQV Specialist in Raritan, NJ to support commissioning, qualification and validation for a cell therapy manufacturing environment. The role emphasizes compliance, audits, and mentoring junior engineers.

This is a 6-month, onsite contract with comprehensive benefits. The ideal candidate has 8+ years in CQV within pharma/biotech settings, with strong knowledge of cGMP, cGTP, and regulatory expectations.

Qualifications

• Bachelor’s degree in Science, Engineering, or related technical discipline.
• 8+ years of CQV experience within pharma/biotech/cell therapy environments.
• Strong knowledge of cGMP, cGTP, FDA/EU regulations, and validation lifecycle.

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and processes.
• Author and execute CQV protocols, reports, and documentation ensuring compliance and data integrity.
• Lead or support deviations, investigations, CAPAs, corrections, and remediation efforts.
• Manage multiple CQV projects 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.

Skills

CQV experience

Audits & inspections

Mentoring juniors

Independent worker

Education

Bachelor’s degree in Science or Engineering

Tools

Kneat

Maximo

Siemens EMS

Comet

Kaye AVS

Kaye ValProbe

Job description

Piper Companies is seeking a Sr CQV Specialist in Raritan, NJ to support commissioning, qualification and validation for a cell therapy manufacturing environment. The role emphasizes compliance, audits, and mentoring junior engineers.

This is a 6-month, onsite contract with comprehensive benefits. The ideal candidate has 8+ years in CQV within pharma/biotech settings, with strong knowledge of cGMP, cGTP, and regulatory expectations.