Senior CQV Engineer – Cell Therapy Validation Lead

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 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.