Principal Validation Engineer

Rentschler Biopharma; Milford (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Rentschler Biopharma seeks a Principal Validation Engineer to lead hands-on validation activities across manufacturing, QC, and supply chain processes. You will develop and execute CQV protocols, qualification reports, and support the lifecycle validation lifecycle for complex systems, including Cleaning Validation.

The role requires deep knowledge of ASTM E2500 principles in CDMO environments, strong technical writing, and demonstrated project leadership across cross-functional teams."

Qualifications

• Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, Life Sciences) or related scientific discipline.
• 7+ years of hands‑on validation experience in pharmaceutical/biotech industries.
• Experience in managing projects (CAPEX/OPEX) and leading cross-functional teams.
• Champion to adopt ASTM E2500 in CDMO manufacturing operations environment.
• Excellent technical writing ability for technical and compliance reports or submissions.
• Detailed knowledge of disposable technology preferred.

Responsibilities

• Develop and execute CQV protocols and reports.
• Perform lifecycle qualification (DQ, FAT, SAT, IOPQ) of manufacturing, QC, and supply chain equipment.
• Maintain equipment and processes in a validated state, including Cleaning Validation.
• Lead cross-functional project teams and drive validation milestones.

Skills

Hands-on validation

Technical writing

Cross-functional leadership

Project coordination

Education

Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, Life Sciences) or related discipline

Tools

Disposable technology

Job description

Principal Validation Engineer position is a member of Validation Team (under Engineering Department umbrella) to demonstrate hands‑on experience in developing and executing specifications, operating procedures, commissioning/qualification/validation (CQV) protocols and reports to perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain process equipment (including Cleaning Validation) and maintain them in validated state.

This position is responsible for lifecycle qualification of our manufacturing facilities to support concurrent manufacturing operations.

Quallifications:

• Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.), Life Sciences, or related scientific discipline.
• 7+ years of hands‑on, direct validation experiences in pharmaceutical / biotech industries, including minimum 3 years of managing projects (CAPEX/OPEX).
• Champion to adopt / apply principles of ASTM E2500 in CDMO manufacturing operations environment.
• Excellent technical writing ability for technical and compliance reports or submission.
• Experience in managing multiple projects and leading cross-functional project teams desired.
• Detailed knowledge of disposable technology preferred.