Sr. Mgr, Engineering Manager

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.

Responsibilities

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; Coordinate facility inspections, repairs, maintenance activities, and utility monitoring programs; Ensure adequate capacity planning and infrastructure support; Maintain facility drawings, engineering documentation, equipment records, and maintenance history files; Ensure team completion of required safety training and compliance with site safety policies; Partner with EHS manager to manage facility emergency response programs, evacuation plans, and business continuity preparedness; Ensure contractor compliance with site safety requirements; Member of site EHS committee; Ensure compliance with FDA regulations, Quality System Regulations, ISO standards, OSHA requirements, environmental regulations, and company policies; Partner with Quality Assurance to maintain the Quality Management System and support inspection readiness; Support internal audits, customer audits, and regulatory inspections; Ensure engineering and facilities documentation follows Good Documentation Practices; Participate in management reviews, risk assessments, and continuous improvement activities; Ensure personnel are properly trained and qualified; Coordinate EHS orientation and ongoing safety training programs; Support development of training curricula; Promote employee engagement, professional development, and technical competency growth; Directly manage facilities and maintenance managers, supervisors, engineers, and technicians

Requirements

Bachelor's degree with a minimum of 8 years of relevant engineering, facilities, maintenance, or EHS experience; Minimum of 3 years of leadership experience in a regulated manufacturing environment

Nice to have

Experience in medical device, biologics, tissue technologies, pharmaceuticals, or other FDA-regulated industries; Master's degree in Engineering, Environmental Health & Safety, Facilities Management, or Business Administration; Professional Engineering (PE), Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), or similar certification; Lean Six Sigma Green Belt or Black Belt certification; Experience supporting FDA inspections and ISO audits

Benefits

Medical; dental; vision; life insurance; short- and long-term disability; business accident insurance; group legal insurance; savings plan (401(k))