Senior CQV Engineer, Cell Therapy Manufacturing

Piper Companies; Raritan (NJ); On-site; USD 69,000 - 79,000; Full time

Benefits offered by this job

Medical, dental, vision

Retirement plans

6 Month Contract

Job summary

Piper Companies in Raritan, NJ is seeking a Senior Validation Engineer to lead CQV activities for cell therapy manufacturing in a highly regulated cGMP environment. You will oversee commissioning, qualification, and validation of equipment, utilities, and facilities, and collaborate with Manufacturing, Engineering and Quality teams as well as external vendors.

The ideal candidate has 8+ years CQV/validation experience, a Bachelor’s degree in Engineering or Life Sciences, and strong knowledge of

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 8+ years CQV/validation experience in a cGMP-regulated environment (pharma/biotech/cell therapy).
• Ability to independently execute validation activities and lead projects from initiation through completion.
• Experience authoring and executing validation documentation including protocols, reports, SOPs, and change controls.

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for manufacturing equipment, utilities, facilities, and systems supporting cell therapy production.
• Write, review, and execute CQV protocols, summary reports, risk assessments, change controls, and related documentation while ensuring data integrity and regulatory compliance.
• Lead technical investigations, deviations, CAPAs, remediation efforts, and corrective actions associated with CQV activities.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality, and external vendors to drive validation projects through successful completion.
• Support regulatory inspections and internal audits by presenting validation strategies, documentation, and program outcomes.
• Mentor junior team members and provide guidance on qualification programs, documentation development, and validation best practices.

Skills

CQV experience

Validation leadership

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

CQV protocols

Documentation reviews

Job description

Piper Companies in Raritan, NJ is seeking a Senior Validation Engineer to lead CQV activities for cell therapy manufacturing in a highly regulated cGMP environment. You will oversee commissioning, qualification, and validation of equipment, utilities, and facilities, and collaborate with Manufacturing, Engineering and Quality teams as well as external vendors.

The ideal candidate has 8+ years CQV/validation experience, a Bachelor’s degree in Engineering or Life Sciences, and strong knowledge of