Sr. Mgr, Engineering Manager

Changing lives. Building Careers.   Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Manager, Engineering Manager is responsible for the leadership, management, and continuous improvement of engineering, facilities, maintenance, utilities, and his team's compliance with site and company environmental health and safety (EHS) programs. This role ensures that facilities, equipment, utilities, and infrastructure are maintained in a state of compliance and operational readiness to support manufacturing operations. The Senior Manager, Engineering Manager partners with Operations, Quality, Supply Chain, and other functional groups to drive operational excellence, facility reliability, regulatory compliance, workplace safety, and continuous improvement initiatives. SUPERVISION EXERCISED  Under direct supervision of the Plant Manager this position will directly manage facilities and maintenance managers, supervisors, engineers, and technicians.

Engineering and Facilities Management  Lead engineering, facilities, maintenance, and utility operations to support manufacturing and business objectives.  Ensure facilities, equipment, utilities, and infrastructure are maintained in compliance with applicable regulatory, safety, and quality requirements.  Develop and implement preventive maintenance, calibration, reliability, and asset management programs.  Manage engineering projects, facility modifications, equipment installations, utility upgrades, and capital improvement initiatives.  Provide technical leadership for equipment qualification, facility validation, process improvements, and continuous improvement activities.  Support manufacturing operations by identifying and resolving equipment, facilities, and process-related issues.  Develop departmental budgets, capital expenditure plans, and resource forecasts.  Manage contractors, vendors, and service providers to ensure work is completed safely, efficiently, and in compliance with company requirements.  Coordinate facility inspections, repairs, maintenance activities, and utility monitoring programs.  Ensure adequate capacity planning and infrastructure support for current and future business needs.  Maintain facility drawings, engineering documentation, equipment records, and maintenance history files.  Environmental, Health and Safety Responsibilities  Ensure his team’s completion of all required safety training and their compliance with site safety policies and procedures.  Partner with EHS manager to manage facility emergency response programs, evacuation plans, and business continuity preparedness activities.  Ensure contractor compliance with site safety requirements.  Member of site EHS committee.    Quality and Compliance Responsibilities  Ensure compliance with applicable FDA regulations, Quality System Regulations, ISO standards, OSHA requirements, environmental regulations, and company policies and procedures.  Partner with Quality Assurance to maintain the effectiveness of the Quality Management System and support inspection readiness activities.  Support internal audits, customer audits, and regulatory inspections.  Ensure engineering and facilities documentation is maintained in accordance with Good Documentation Practices and quality system requirements.  Participate in management reviews, risk assessments, and continuous improvement activities.  Training and Development  Ensure personnel are properly trained and qualified to perform assigned responsibilities.  Coordinate EHS orientation training and ongoing safety training programs.  Support development of training curricula for engineering,