Description

You will support manufacturing activities for cGMP equipment and facilities, ensuring equipment reliability, safety, and quality compliance.

Responsibilities

• Own equipment performance and accountability for deliverables on key capital projects.
• Suggest design modifications to mitigate risks and integrate quality and safety into designs.
• Oversee verification deliverables developed by contract staff and ensure validation protocols meet cGMP documentation standards.
• Act as the technical liaison between Engineering and Quality Assurance during project lifecycles.
• Lead root cause analysis and multidisciplinary teams to support Lean Transformation and operational excellence.
• Defend equipment-specific calibration, maintenance, and validation during regulatory inspections.

Required Skills

• 7+ years of relevant work experience with 5+ years in an operations or manufacturing environment.
• Direct experience working in regulated environments (FDA, OSHA, EPA).
• Working knowledge of cGMP procedures and engineering practices for pharmaceutical/biotech production, clean utilities, and facilities.
• Experience implementing risk-based verification on major GMP process equipment or automation projects.
• Knowledge of process equipment including cell culture, fermentation, purification, and filling.
• Technical writing skills for developing SOPs and validation protocols.
• Understanding of process improvement methodologies such as LEAN, Six Sigma, or PDCA.
• Background in Biomedical Engineering, Biotechnology, or Chemical Engineering.

Preferred Skills

• Knowledge of Delta V, Rockwell, and Plant Information Systems.
• Experience with combination product or medical device quality systems verification.

Key Skills

Education

Any Graduate