Manager, GMP Facility, Asset Readiness & HSE

Job Title: Manager, GMP Facility, Asset Readiness & HSELocation: Pearl River, NYAbout the Job Leads GMP facility readiness, equipment asset care, and HSE compliance to ensure the manufacturing shopfloor is maintained in a GMP-ready and safety-ready state at all times. Oversees GMP cleaning operations, manages two dedicated maintenance technicians for asset care, and partners with Maintenance teams on equipment PM, calibration, and shutdown planning. Dedicates 25-50% of time to HSE activities including safe work practices, 5S implementation, work permitting, and safety compliance. Ensures attention to facility details including rust, cleaning residue, paint integrity, and floor conditions while maintaining all GMP documentation and environmental monitoring requirements. Leads GMP facility readiness, equipment asset care, and HSE compliance to ensure the manufacturing shopfloor is maintained in a GMP-ready and safety-ready state at all times. This role is accountable for facility cleanliness, equipment reliability, asset care management, and health, safety & environment compliance across all manufacturing operations.Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi:We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.Main ResponsibilitiesGMP Facility & Cleaning OperationsEnsure the manufacturing facility is maintained in a GMP-ready and safety-ready state at all timesOversee and coordinate GMP cleaning operations of all manufacturing areas in compliance with cleaning procedures and validation requirementsPartner 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 deficienciesConduct regular facility walkthroughs to identify and remediate GMP and safety deficienciesMaintain cleaning logs, records, and documentation in compliance with GMP requirementsEnsure environmental monitoring requirements are supported and met within the manufacturing facilityEquipment Asset Care & MaintenanceDirectly manage two dedicated maintenance technicians focused on asset care and equipment readinessEnsure all manufacturing equipment is clean, calibrated, and current with preventive maintenance (PM) schedulesPartner with the Maintenance team to define scope of work, planning, and execution of maintenance shutdownsMaintain equipment status boards and asset care records to ensure full traceability and GMP complianceProactively identify equipment reliability risks and drive resolution through appropriate channelsSupport equipment qualification activities (IQ/OQ/PQ) and change control processes as neededHealth, Safety & Environment (HSE) — 25–50% of RoleChampion a culture of safety across the manufacturing shopfloorEnsure safe work practices are understood, followed, and reinforced among all team members and contractorsManage and coordinate work permitting processes (e.g., confined space, hot work, lockout/tagout)Lead and sustain 5S implementation and continuous improvement across manufacturing areasConduct safety walkthroughs, hazard assessments, and near-miss investigationsEnsure compliance with all applicable HSE regulations, site policies, and Sanofi standardsServe as a key point of contact for HSE topics on the manufacturing shopfloorTeam Leadership & CollaborationLead, develop, and manage two dedicated asset care maintenance techniciansCollaborate cross-functionally with Maintenance, Quality, and Manufacturing teamsCoordinate with cleaning contractor management to ensure GMP and safety standards are consistently metParticipate in deviation investigations related to facility, equipment, or cleaning deficienciesSupport regulatory inspections and internal audits related to facility and equipment readinessBasic QualificationsBachelor's degree2+ years of experience in a GMP biopharmaceutical or pharmaceutical manufacturing environment.Demonstrated experience managing facility readiness, equipment maintenance, or asset care programsProven experience implementing and sustaining 5S methodology in a manufacturing environmentExperience coordinating with maintenance teams and/or third-party contractorsFamiliarity with HSE programs including safe work practices, permitting, and safety compliance.Technical KnowledgeWorking knowledge of cGMP regulations (21 CFR Parts 210, 211) and GMP cleaning requirementsUnderstanding of environmental monitoring principles and practices in a manufacturing settingKnowledge of preventive maintenance, calibration programs, and equipment qualificationExperience with 5S implementation and workplace organizationFamiliarity with work permitting systems and HSE compliance requirements PREFERRED QUALIFICATIONSExperience in vaccine, biologics, or recombinant protein manufacturingOSHA 30-hour certification or equivalent HSE trainingExperience managing third-party cleaning or maintenance contractorsKnowledge of cleaning validation principlesLean Manufacturing or Six Sigma training Soft SkillsStrong attention to detail and commitment to GMP and safety standardsProactive problem-solving and facility management skillsEffective leadership and team development capabilitiesStrong communication and cross-functional collaboration skillsAbility to manage multiple priorities in a fast-paced manufacturing environmentContinuous improvement mindset with hands-on approach PHYSICAL REQUIREMENTSAbility to work in a manufacturing environment including cleanroom gowning requirementsRegular walking and standing during facility inspections and shopfloor activitiesOccasional lifting up to 35 lbsFlexibility 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 scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime. Sanofi US Services and its U.S. affiliates are