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.
