Manager, GMP Facility and HSE Readiness
21 days ago
Mount Vernon
Job Title: Manager, GMP Facility and HSE Readiness Location: Pearl River, NY About the Job Manager, GMP Facility and HSE Readiness is a pivotal operational leadership role responsible for maintaining our Pearl River manufacturing facility in a state of GMP compliance, equipment readiness, and workplace safety excellence. You will lead a team of two maintenance technicians while orchestrating facility operations across GMP cleaning, equipment asset care, and HSE leadership. Your meticulous attention to detail, proactive problem-solving, and hands-on approach will ensure our manufacturing environment meets the highest standards of regulatory compliance and operational integrity—directly enabling Sanofi to deliver life-saving medicines to patients worldwide. About Sanofi: We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Main Responsibilities GMP Facility & Cleaning Operations (primary focus): • Ensure the manufacturing facility is maintained in a GMP-ready and safety-ready state at all times, • Oversee and coordinate GMP cleaning operations of all manufacturing areas in compliance with cleaning procedures and validation requirements, • Partner with third-party cleaning contractor to ensure thorough execution of cleaning activities, with attention to detail including rust, cleaning residue, paint integrity, floor conditions, and other facility deficiencies, • Conduct regular facility walkthroughs to identify and remediate GMP and safety deficiencies, • Maintain cleaning logs, records, and documentation in compliance with GMP requirements, • Ensure environmental monitoring requirements are supported and met within the manufacturing facility Equipment Asset Care & Maintenance: • Directly manage two dedicated maintenance technicians focused on asset care and equipment readiness, • Ensure all manufacturing equipment is clean, calibrated, and current with preventive maintenance (PM) schedules, • Partner with the Maintenance team to define scope of work, planning, and execution of maintenance shutdowns, • Maintain equipment status boards and asset care records to ensure full traceability and GMP compliance, • Proactively identify equipment reliability risks and drive resolution through appropriate channels, • Support equipment qualification activities (IQ/OQ/PQ) and change control processes as needed, • Review and Close Preventive and Corrective workorders as the pertain to the Manufacturing floor -Execute and complete Corrective and Preventive Actions (CAPAs) as applicable Health, Safety & Environment (HSE) - 25-50% of role: • Champion a culture of safety across the manufacturing shopfloor, • Ensure safe work practices are understood, followed, and reinforced among all team members and contractors, • Manage and coordinate work permitting processes (e.g., confined space, hot work, lockout/tagout), • Lead and sustain 5S implementation and continuous improvement across manufacturing areas, • Conduct safety walkthroughs, hazard assessments, and near-miss investigations, • Ensure compliance with all applicable HSE regulations, site policies, and Sanofi standards, • Serve as a key point of contact for HSE topics on the manufacturing shopfloor Team Leadership & Collaboration: • Lead, develop, and manage two dedicated asset care maintenance technicians, • Collaborate cross-functionally with Maintenance, Quality, and Manufacturing teams, • Coordinate with cleaning contractor management to ensure GMP and safety standards are consistently met, • Participate in deviation investigations related to facility, equipment, or cleaning deficiencies, • Support regulatory inspections and internal audits related to facility and equipment readiness About You Basic Qualifications • Bachelor's degree in engineering, Biology, Life Sciences, or related field required or 5+ years of equivalent experience in a GMP biopharmaceutical or pharmaceutical manufacturing environment. -5+ years of experience in GMP equipment maintenance, asset care, or reliability programs in a biopharmaceutical or pharmaceutical manufacturing environment. • Demonstrated experience managing facility readiness, equipment maintenance, or asset care programs, • Proven experience implementing and sustaining 5S methodology in a manufacturing environment., • Experience coordinating with maintenance teams and/or third-party contractors, • Familiarity with HSE programs including safe work practices, permitting, and safety compliance Technical Knowledge: • Working knowledge of cGMP regulations (21 CFR Parts 210, 211) and GMP cleaning requirements, • Understanding of environmental monitoring principles and practices in a manufacturing setting, • Knowledge of preventive maintenance, calibration programs, and equipment qualification, • Experience with 5S implementation and workplace organization, • Familiarity with work permitting systems and HSE compliance requirements Soft Skills: • Strong attention to detail and commitment to GMP and safety standards, • Proactive problem-solving and facility management skills, • Effective leadership and team development capabilities, • Strong communication and cross-functional collaboration skills, • Ability to manage multiple priorities in a fast-paced manufacturing environment, • Continuous improvement mindset with hands-on approach Preferred Qualifications • Experience in vaccine, biologics, or recombinant protein manufacturing, • OSHA 30-hour certification or equivalent HSE training, • Experience managing third-party cleaning or maintenance contractors, • Knowledge of cleaning validation principles, • Lean Manufacturing or Six Sigma training Physical Requirements • Ability to work in a manufacturing environment including cleanroom gowning requirements, • Regular walking and standing during facility inspections and shopfloor activities, • Occasional lifting up to 35 lbs, • Flexibility to respond to facility or equipment issues outside of standard business hours Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale Transform lives worldwide by delivering life-changing treatments anywhere, anytime. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.