Senior Validation Engineer - 174413

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

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking a Senior Validation Engineer to support CQV activities in a cell therapy manufacturing environment in Raritan, NJ. The role focuses on commissioning, qualification, and validation execution within a highly regulated cGMP setting.

The Senior Validation Engineer will write and review CQV protocols and reports, lead investigations, and mentor junior staff while coordinating with Manufacturing, Quality, and external vendors to drive validation programs to completion.

Qualifications

• 8+ years CQV/validation experience in a cGMP-regulated environment.
• Experience authoring and executing validation documentation including protocols and reports.
• Ability to lead validation projects from initiation through completion.
• Familiarity with cGMP, cGTP, ICH guidelines and 21 CFR Parts 210, 211, 1271.

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for equipment, utilities, facilities, and systems for cell therapy production.
• Write, review and execute CQV protocols, summary reports, risk assessments, change controls and related docs.
• Lead investigations, deviations, CAPAs, and remediation efforts related to CQV activities.
• Collaborate with Manufacturing, Engineering, Quality and external vendors to drive validation projects to completion.
• Support regulatory inspections and internal audits by presenting validation strategies and outcomes.
• Mentor junior team members and provide guidance on qualification programs and documentation.

Skills

CQV/Validation experience

Leadership & project management

Documentation writing

Regulatory knowledge (cGMP/21 CFR)

CAR-T/cell therapy experience

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Piper Companies is seeking a Senior Validation Engineer to support commissioning, qualification, and validation activities within a cutting-edge cell therapy manufacturing environment in Raritan, NJ. The Senior Validation Engineer will play a critical role in ensuring compliant manufacturing processes, equipment qualification, and validation execution while supporting both clinical and commercial production in a highly regulated cGMP setting.

Responsibilities of the Senior Validation Engineer:

• 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.

Qualifications of the Senior Validation Engineer:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 8+ years of CQV, validation, commissioning, or qualification experience within a cGMP-regulated pharmaceutical, biotechnology, or cell therapy environment.
• Strong equipment qualification experience with the ability to independently execute validation activities and lead projects from initiation through completion.
• Experience authoring and executing validation documentation including protocols, reports, SOPs, work instructions, risk assessments, and change controls.
• Working knowledge of cGMP, cGTP, ICH guidelines, and 21 CFR Parts 210, 211, and 1271; experience with CAR-T or cell therapy manufacturing is highly preferred.

Compensation for the Senior Validation Engineer includes:

• Pay Range: $50-$57 per hour (depending on experience),
• Comprehensive benefits package including medical, dental, vision, and retirement plans
• 6 Month Contract

This job opens for applications on 09/14/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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