Senior Validation Engineer

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 seeks a Senior Validation Engineer to lead commissioning, qualification, and validation activities for cell therapy production in a cGMP environment at the Raritan, NJ site.

The role involves authoring CQV protocols, risk assessments, and change controls; leading investigations and CAPAs; and collaborating with Manufacturing, Quality, and external vendors to ensure compliant validation programs.

Qualifications

• 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; CAR-T or cell therapy manufacturing is highly preferred.

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 execution

Documentation development

Regulatory compliance

Risk assessments

Education

Bachelor's degree in Engineering/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

• 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 09/21/2026. Applications for this job will be accepted for at least 30 days from the posting date.

SEO Keywords

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