Senior Validation Engineer - CQV Leader

Rentschler Biopharma, Inc.; Milford, Northern (MA, KY); Hybrid; USD 140,000 - 170,000; Full time

Job summary

Rentschler Biopharma, Inc. in Milford, MA is seeking a Principal Validation Engineer to lead lifecycle qualification for manufacturing, QC, and supply chain equipment.

You will develop and execute CQV protocols, drive risk-based validation, and ensure compliance with cGMPs in a fast-paced biopharma environment. The role requires strong project leadership, cross-functional communication, and the ability to train engineering teams on validation programs.

Qualifications

• Bachelor’s Degree or equivalent in Engineering, Life Sciences, or related field.
• 7+ years hands-on validation experience in pharma/biotech.
• 3+ years managing projects (CAPEX/OPEX).
• Experience with cGMPs and Good Engineering Practices.
• Excellent technical writing for reports or submissions.
• Knowledge of ASTM E2500 principles.

Responsibilities

• Maintain Equipment/Facility/Utilities (EFU), CSV and Cleaning Validation programs per Validation Master Plan.
• Lead complex, high-priority validation projects with cross-functional teams.
• Apply ASTM E2500 and risk-based approaches to CQV activities.
• Coordinate CQV deliverables with Manufacturing, Engineering, Process Support, Supply Chain, Quality and Regulatory affairs.
• Provide leadership and training on validation programs and lifecycle.

Skills

ASTM E2500

Technical writing

Cross-functional collaboration

Project management

cGMPs knowledge

Validation lifecycle

Education

Bachelor’s Degree or equivalent in Engineering

Job description

Rentschler Biopharma, Inc. in Milford, MA is seeking a Principal Validation Engineer to lead lifecycle qualification for manufacturing, QC, and supply chain equipment.

You will develop and execute CQV protocols, drive risk-based validation, and ensure compliance with cGMPs in a fast-paced biopharma environment. The role requires strong project leadership, cross-functional communication, and the ability to train engineering teams on validation programs.