Senior CQV Engineer: Onsite Cell Therapy Validation Lead

Piper Companies; Raritan (NJ); On-site; USD 83,000 - 90,000; Part time

Job summary

Piper Companies is seeking a Senior CQV Engineer (Commissioning, Qualification & Validation) for a cell therapy program in Raritan, NJ. This 100% onsite role focuses on CQV activities across facilities, utilities, equipment, and manufacturing systems in a cGMP environment.

The candidate should have 8+ years CQV experience, strong leadership across multiple projects, and expertise in IQ/OQ/PQ protocols, risk assessments, and validation lifecycle.

Qualifications

• 8+ years CQV experience in regulated pharma/biotech environments.
• Proven ability to manage multiple CQV projects concurrently.
• Experience authoring IQ/OQ/PQ protocols and validation documents.
• Strong knowledge of cGMP/cGTP and regulatory guidance (FDA/ICH).

Responsibilities

• Execute CQV activities for facilities, utilities, equipment, and systems.
• Lead multiple CQV projects ensuring timelines and compliance.
• Author and review CQV protocols, reports, and risk assessments.
• Support audits and change controls in a regulated setting.

Skills

CQV experience

IQ/OQ/PQ protocols

Validation lifecycle

Regulatory compliance

Cross-functional collaboration

Project management

GxP knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye

AVS

Kaye ValProbe

Job description

Piper Companies is seeking a Senior CQV Engineer (Commissioning, Qualification & Validation) for a cell therapy program in Raritan, NJ. This 100% onsite role focuses on CQV activities across facilities, utilities, equipment, and manufacturing systems in a cGMP environment.

The candidate should have 8+ years CQV experience, strong leadership across multiple projects, and expertise in IQ/OQ/PQ protocols, risk assessments, and validation lifecycle.