Senior Validation Engineer – CQV Project Lead

Rentschler Biopharma, Inc.; Milford (MA); On-site; USD 140,000 - 170,000; Full time

Job summary

Rentschler Biopharma, Inc. is seeking a Principal Validation Engineer in Milford, MA. The role leads CQV activities for manufacturing, QC, and supply chain equipment, ensuring compliant lifecycle qualification and validated state across facilities.

You will collaborate with Manufacturing, Engineering, Process Support, and Regulatory Affairs to drive CQV deliverables, staying aligned with current regulations and industry practices, while mentoring teams and supporting audits.

Qualifications

• Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.)
• 7+ years of hands-on validation experience in pharma/biotech, incl. 3+ years managing projects
• Experience applying ASTM E2500 in CDMO manufacturing operations
• Must have knowledge of cGMPs and Good Engineering Practices
• Excellent technical writing for compliance reports or submissions

Responsibilities

• Maintain EFU, CSV and Cleaning Validation programs per Validation Master Plan
• Lead complex validation projects requiring high resource levels
• Apply ASTM E2500 and sound engineering practices to Site Validation lifecycle
• Communicate project status and escalate issues promptly
• Collaborate with cross-functional teams to ensure CQV deliverables meet regulations
• Provide QA leadership in validation documentation for audits
• Train engineering teams on validation programs and lifecycle
• Direct validation specialists to resolve technical challenges and coordinate qualifications

Skills

Validation

cGMPs

ASTM E2500

Project management

Engineering principles

Education

Bachelor's degree in Engineering

Job description

Rentschler Biopharma, Inc. is seeking a Principal Validation Engineer in Milford, MA. The role leads CQV activities for manufacturing, QC, and supply chain equipment, ensuring compliant lifecycle qualification and validated state across facilities.

You will collaborate with Manufacturing, Engineering, Process Support, and Regulatory Affairs to drive CQV deliverables, staying aligned with current regulations and industry practices, while mentoring teams and supporting audits.