Facility Engineer
2 days ago
Edison
Company Description PLS Analytical provides comprehensive testing services for regulated product programs, specializing in nasal drug products, microbiological, analytical, and packaging component testing. The company offers innovative solutions for product characterization and risk assessment, including Particle Size Analysis and Nitrosamine Testing. Serving the pharmaceutical, nutraceutical, dietary supplement, cosmetic, and food industries, PLS Analytical operates as an FDA- and DEA-registered contract laboratory with CGMP and ISO 17025 certifications. Committed to quality, PLS Analytical also supports private label OTC manufacturing, packaging, and distribution through its partner network. Learn more at . Position Summary This is a full-time, on-site role for a Facility Engineer based in East Brunswick, NJ. The Facility Engineer will play a key role in managing facility operations in a cGMP-regulated pharmaceutical environment. This role is responsible for the maintenance, repair, and continuous improvement of HVAC systems, electrical and mechanical equipment, critical utilities and overall facility infrastructure. The Facility Engineer will oversee preventive maintenance planning, scheduling, contractor coordination and ensure all work is completed in compliance with cGMP, safety, and regulatory standards. Accurate cGMP documentation, system reliability, and operational efficiency are essential to success in this role. Key Responsibilities • Oversee the design, planning, construction, installation and maintenance of building systems, equipment and facility infrastructure., • Ensure all facility operations comply with FDA, cGMP, and safety regulations, including maintenance of required documentation., • Develop, execute and review IQ/OQ/PQ protocols for equipment, utilities, and in-process machinery., • Install, qualify and upgrade pharmaceutical manufacturing equipment as needed., • Troubleshoot electrical, mechanical, and integrated control systems for manufacturing machinery., • Lead and coordinate commissioning, installation, and validation activities with internal teams and external contractors., • Manage facility upgrades, electrical engineering projects and site expansion initiatives., • Evaluate project requirements , capacity constraints and cost estimates to support business needs., • Drive cost reduction, efficiency optimizations, safety improvements, and equipment reliability initiatives., • Supervise and support facility maintenance personnel, including mechanics and engineers., • Coordinate with warehouse , production and laboratory teams on facility support needs., • Implement and maintain preventive maintenance and calibration programs., • Lead EHS (Environment, Health, Safety) activities, including employee safety training and compliance., • Conduct risk assessments and support CAPA, FMEA and DFMEA activities., • Analyze facility performance data and maintenance reports to develop continuous implement plans. Qualifications • Strong expertise in Facilities Engineering and Facility Management (FM) to oversee and maintain building systems and equipment, at least 2 years of experience in the position offered., • Proficiency in Facilities Operations, including maintenance schedules and compliance with safety standards, • Ability to troubleshoot technical problems and resolve issues efficiently, • Experience with Preventive Maintenance programs to ensure equipment reliability, • Understanding of safety regulations and building codes, • Strong analytical and decision-making skills, • Bachelor’s degree in Engineering, Facilities Management, or a related field preferred, • Industry certification or licenses related to facility management is a plus