Senior CQV Validation Engineer — Lead Projects & Compliance

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

Job summary

Rentschler Biopharma Inc. is seeking a Principal Validation Engineer to drive lifecycle qualification for manufacturing, QC, and supply chain equipment. The role emphasizes CQV, risk-based validation, and collaboration across Manufacturing, Engineering and Regulatory Affairs.

You will lead validation projects, ensure GMP compliance, and mentor teams on validation practices while maintaining robust quality systems and documentation.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 7+ years hands-on validation in pharma/biotech, including CAPEX/OPEX project leadership.
• Experience with cGMPs and Good Engineering Practices, strong technical writing.

Responsibilities

• Maintain EFU, CSV, and Cleaning Validation programs per site policies.
• Lead complex validation projects requiring cross-functional resources.
• Apply ASTM E2500 principles to site validation lifecycle.
• Communicate validation status and potential issues to stakeholders.
• Collaborate with Manufacturing, Engineering, QA and Regulatory to ensure CQV deliverables.
• Mentor engineers on validation programs and lifecycle.

Skills

Validation

cGMP

Project management

Technical writing

Cross-functional collaboration

ASTM E2500

Quality systems

Disposable technology

CQV

Engineering practices

Education

Bachelor’s Degree in Engineering

Tools

CSV

Job description

Rentschler Biopharma Inc. is seeking a Principal Validation Engineer to drive lifecycle qualification for manufacturing, QC, and supply chain equipment. The role emphasizes CQV, risk-based validation, and collaboration across Manufacturing, Engineering and Regulatory Affairs.

You will lead validation projects, ensure GMP compliance, and mentor teams on validation practices while maintaining robust quality systems and documentation.