Principal Validation Engineer in Milford

Energy Jobline ZR; Milford (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

Energy Jobline ZR is seeking a Principal Validation Engineer to lead lifecycle qualification of manufacturing facilities and develop CQV protocols across DQ, FAT, SAT, and IOPQ. The role requires strong hands-on validation in pharma/biotech, with three or more years managing cross-functional projects.

The candidate will oversee ed validation of cleaning processes and ensure all systems remain in a validated state, driving quality and compliance throughout the lifecycle.

Qualifications

• Bachelor’s degree in engineering or related field.
• 7+ years validation experience in pharma/biotech.
• 3+ years project management experience.
• Experience with cleaning validation and CQV lifecycle.

Responsibilities

• Perform lifecycle qualification of manufacturing facilities.
• Develop and execute CQV protocols and reports.
• Demonstrate hands-on validation of equipment and processes.
• Lead cross-functional validation projects.

Skills

Project management

Technical writing

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in engineering or related field

Job description

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 , 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.