Senior CQV Engineer — Onsite Validation Lead

Piper Companies; Raritan (NJ); On-site; USD 170,822,000 - 185,976,000; Part time

Job summary

Piper Companies is seeking a Senior CQV Engineer to support commissioning, qualification and validation activities for cell therapy manufacturing in Raritan, NJ. This onsite role focuses on CQV for facilities, utilities, equipment, and manufacturing systems with direct collaboration across Quality, Manufacturing, Engineering and Validation teams.

The candidate will lead CQV projects, author critical validation documentation, drive risk-based validation strategies, and support inspections and

Qualifications

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

Responsibilities

• Execute CQV activities for facilities, utilities, equipment and manufacturing systems.
• Lead multiple CQV projects ensuring timelines, deliverables and compliance.
• Author/review CQV protocols, reports, risk assessments and validation docs.
• Provide technical guidance to junior CQV team members and support audits.

Skills

CQV experience

Project management

Regulatory knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye ValProbe

Job description

Piper Companies is seeking a Senior CQV Engineer to support commissioning, qualification and validation activities for cell therapy manufacturing in Raritan, NJ. This onsite role focuses on CQV for facilities, utilities, equipment, and manufacturing systems with direct collaboration across Quality, Manufacturing, Engineering and Validation teams.

The candidate will lead CQV projects, author critical validation documentation, drive risk-based validation strategies, and support inspections and