Senior CQV Specialist: Cell Therapy Validation & Compliance

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

PTO

Paid Holidays

Job summary

Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a cell therapy manufacturing organization in Raritan, NJ. This role emphasizes hands-on CQV for facilities, equipment, utilities, and processes, with a focus on data integrity and regulatory readiness.

The position requires authoring CQV protocols and reports, leading investigations and CAPAs, mentoring junior engineers, and collaborating with cross-functional teams.

Qualifications

• Bachelor’s degree in Science, Engineering, or a related technical discipline.
• 8+ years of CQV experience within 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.
• 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.

Responsibilities

• 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.

Skills

cGMP knowledge

Regulatory compliance

Mentoring juniors

Quality investigations

Education

Bachelor’s degree in Science, Engineering or related field

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 cell therapy manufacturing organization in Raritan, NJ. This role emphasizes hands-on CQV for facilities, equipment, utilities, and processes, with a focus on data integrity and regulatory readiness.

The position requires authoring CQV protocols and reports, leading investigations and CAPAs, mentoring junior engineers, and collaborating with cross-functional teams.