Manager, GMP Facility, Asset Readiness & HSE
Sanofi
August 23, 2026
On-site
Pearl River, NY
$78,000 - $112,666.66 USD yearly
Operations
Main Responsibilities
- Ensure the manufacturing facility is maintained in a GMP-ready and safety-ready state at all times.
- Oversee and coordinate GMP cleaning operations per cleaning procedures and validation requirements.
- Partner with third-party cleaning contractors to ensure thorough cleaning (rust, residue, paint integrity, floor conditions, and other deficiencies).
- Conduct regular facility walkthroughs to identify and remediate GMP and safety deficiencies.
- Maintain cleaning logs/records/documentation in compliance with GMP requirements.
- Support and meet environmental monitoring requirements.
- Directly manage two maintenance technicians for asset care and equipment readiness.
- Ensure equipment is clean, calibrated, and current with preventive maintenance (PM).
- Partner with Maintenance to plan and execute maintenance shutdowns.
- Maintain equipment status boards and asset care records for traceability and GMP compliance.
- Identify equipment reliability risks and drive resolution.
- Support IQ/OQ/PQ and change control as needed.
Health, Safety & Environment (HSE) (25–50%)
- Champion safety culture; ensure safe work practices are followed by teams and contractors.
- Manage work permitting (e.g., confined space, hot work, lockout/tagout).
- Lead 5S implementation and continuous improvement.
- Conduct safety walkthroughs, hazard assessments, and near-miss investigations.
- Ensure compliance with HSE regulations/site policies.
- Serve as key point of contact for HSE on the shopfloor.
Basic Qualifications / Technical Knowledge
- Bachelor’s degree.
- 2+ years in GMP biopharma/pharma manufacturing.
- Experience managing facility readiness, equipment maintenance/asset care programs.
- Proven 5S implementation in manufacturing.
- Experience coordinating with maintenance teams and/or third-party contractors.
- Working knowledge of cGMP (21 CFR Parts 210/211) and GMP cleaning requirements; environmental monitoring principles.
Preferred Qualifications
- Vaccine/biologics/recombinant protein experience.
- OSHA 30-hour or equivalent HSE training.
- Experience managing third-party contractors; knowledge of cleaning validation.
- Lean/Six Sigma training.
Soft Skills / Physical
- Strong attention to detail; proactive problem-solving; leadership; communication.
- Ability to work in manufacturing/cleanroom gowning, walk/stand for inspections, lift up to 35 lbs; respond to issues outside normal hours.
- Ensure the manufacturing facility is maintained in a GMP-ready and safety-ready state at all times.
- Oversee and coordinate GMP cleaning operations per cleaning procedures and validation requirements.
- Partner with third-party cleaning contractors to ensure thorough cleaning (rust, residue, paint integrity, floor conditions, and other deficiencies).
- Conduct regular facility walkthroughs to identify and remediate GMP and safety deficiencies.
- Maintain cleaning logs/records/documentation in compliance with GMP requirements.
- Support and meet environmental monitoring requirements.
- Directly manage two maintenance technicians for asset care and equipment readiness.
- Ensure equipment is clean, calibrated, and current with preventive maintenance (PM).
- Partner with Maintenance to plan and execute maintenance shutdowns.
- Maintain equipment status boards and asset care records for traceability and GMP compliance.
- Identify equipment reliability risks and drive resolution.
- Support IQ/OQ/PQ and change control as needed.
Health, Safety & Environment (HSE) (25–50%)
- Champion safety culture; ensure safe work practices are followed by teams and contractors.
- Manage work permitting (e.g., confined space, hot work, lockout/tagout).
- Lead 5S implementation and continuous improvement.
- Conduct safety walkthroughs, hazard assessments, and near-miss investigations.
- Ensure compliance with HSE regulations/site policies.
- Serve as key point of contact for HSE on the shopfloor.
Basic Qualifications / Technical Knowledge
- Bachelor’s degree.
- 2+ years in GMP biopharma/pharma manufacturing.
- Experience managing facility readiness, equipment maintenance/asset care programs.
- Proven 5S implementation in manufacturing.
- Experience coordinating with maintenance teams and/or third-party contractors.
- Working knowledge of cGMP (21 CFR Parts 210/211) and GMP cleaning requirements; environmental monitoring principles.
Preferred Qualifications
- Vaccine/biologics/recombinant protein experience.
- OSHA 30-hour or equivalent HSE training.
- Experience managing third-party contractors; knowledge of cleaning validation.
- Lean/Six Sigma training.
Soft Skills / Physical
- Strong attention to detail; proactive problem-solving; leadership; communication.
- Ability to work in manufacturing/cleanroom gowning, walk/stand for inspections, lift up to 35 lbs; respond to issues outside normal hours.