Senior Manager, Engineering & Facilities

ExtensisHR • Somerset, NJ

3d

About The Position

The Senior Manager, Engineering, Facilities & EHS is responsible for maintaining all manufacturing equipment, utilities, facilities, and environmental, health & safety programs to ensure continuous, compliant production. This role manages capital projects, utilities operations, facility maintenance, safety programs, engineering documentation, and regulatory compliance under cGMP, OSHA, EPA, and state requirements. Responsibilities are carried out personally and through subordinate engineering and maintenance staff.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, Environmental) or equivalent combination of education and experience.
• Five to ten years of progressive engineering, facilities, or regulated manufacturing experience.
• Strong knowledge of: cGMP and FDA regulatory requirements (including 21 CFR 110/111/210/211) OSHA workplace safety regulations and environmental laws (EPCRA, RCRA, Clean Air Act, Clean Water Act) Facility design, utilities engineering, and GMP facility infrastructure Engineering validation principles and lifecycle (IQ/OQ/PQ, DQ) Safety program management, incident investigation, and regulatory compliance
• Experience managing engineering, maintenance, and facilities teams.
• Experience supervising contractors, vendors, and construction activities.
• Strong understanding of preventive maintenance systems, work order systems, and asset management.
• Knowledge of automation systems, robotics, and advanced manufacturing technologies.

Responsibilities

• Engineering, Facilities & Utilities Management Maintain equipment and utilities to ensure uninterrupted production in accordance with established standards and cGMP requirements.
• Manage all facility infrastructure, including HVAC, purified water systems, compressed air, boilers, chillers, cleanrooms, BMS/EMS, and process-related equipment.
• Coordinate plant activities by planning with departmental managers to achieve manufacturing objectives in a timely and cost-effective manner.
• Manage facility services, housekeeping programs, and maintenance operations across laboratories, production areas, and offices.
• Oversee scheduling and execution of all major service activities, repairs, utility outages, and facility shutdowns.
• Capital Projects & Continuous Improvement Lead all capital projects including expansions, equipment installations, facility upgrades, and construction activities.
• Supervise, coordinate, and manage contractors, vendors, and third-party engineering firms on site.
• Develop and manage annual CapEx budgets and spending.
• Identify, evaluate, and implement automation solutions including cobots, robots, and process-improving technologies.
• Drive cost-saving initiatives in energy use, sourcing, maintenance strategy, waste reduction, and in-house vs contracted services.
• Engineering Systems, Validation & Documentation Create, implement, and execute engineering validation protocols (DQ/IQ/OQ/PQ) for both facility and manufacturing equipment.
• Develop, revise, and manage engineering and maintenance SOPs.
• Oversee work order systems, spare parts inventory, preventive maintenance programs, and reliability processes.
• Perform equipment/facility data analysis, gap assessments, risk assessments, and validation studies.
• Be familiar with deviation management, change control processes, and CAPA implementation.
• EHS Management & Regulatory Compliance Manage development, implementation, and ongoing revision of all required EHS programs, training plans, and safety procedures.
• Ensure full compliance with national and state OSHA safety regulations, including: Lockout/Tagout (LOTO) Hazard Communication (HAZCOM/GHS) PPE programs (including safety glasses requirements) Confined space, machine safety, emergency response Powered industrial truck and warehouse safety
• Ensure compliance with environmental regulations related to water, air, hazardous waste, and wastewater (EPA, DEP, NJ state requirements).
• Manage hazardous waste disposal channels and ensure compliant documentation and reporting.
• Conduct EHS audits, incident investigations, root cause analysis, and implement corrective actions.
• Lead fire protection, spill prevention, environmental monitoring, and safety training initiatives.
• Leadership, Team Management & Interdepartmental Support Manage, train, and oversee maintenance technicians, engineers, and facilities personnel.
• Provide leadership and direction for cross-functional and interdepartmental technical training.
• Develop strategies for succession planning and future department growth.
• Meet with internal stakeholders and customers regarding facility or equipment-related needs.
• Customer, Vendor & Stakeholder Management Manage contractors, service providers, and OEM suppliers.
• Meet with clients or partners for facility or equipment-related inquiries.
• Generate and present reports on budgets, facility spending, service contracts, and project status.
• Regulatory & Quality Compliance Ensure compliance with FDA cGMP regulations including 21 CFR Parts 110/111 and 210/211 .
• Prepare for and support FDA, OSHA, EPA, DEP, and internal quality audits.
• Maintain engineering documentation, environmental permits, and compliance records.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior