Senior CQV Specialist — Cell Therapy Validation Lead

Piper Companies; Raritan (NJ); On-site; USD 114,000 - 125,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

PTO & Sick Leave

Paid Holidays

Job summary

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 role focuses on compliant manufacturing operations, audits, investigations, and mentoring junior engineers in a fast-paced environment where each batch impacts patient safety.

Responsibilities include executing CQV tasks, authoring protocols and reports, supporting deviations and CAPAs, and coordinating with

Qualifications

• 8+ years of CQV experience within pharmaceutical, biotech, biologics, or cell therapy manufacturing environments
• Knowledge of cGMP, cGTP, FDA/EU regulations, and validation lifecycle principles
• Experience with investigations, CAPAs, change controls, and remediation activities
• Ability to work with audits and inspections
• Willingness to mentor junior engineers

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 project experience

Strong communication

Mentoring junior engineers

Independent work

Audits & inspections support

Education

Bachelor’s degree in Science/Engineering

Tools

Kneat

Maximo

Siemens EMS

Comet

Kaye AVS

Kaye ValProbe

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 role focuses on compliant manufacturing operations, audits, investigations, and mentoring junior engineers in a fast-paced environment where each batch impacts patient safety.

Responsibilities include executing CQV tasks, authoring protocols and reports, supporting deviations and CAPAs, and coordinating with