Facilities Engineer

We are LOTTE BIOLOGICS Delivering Therapies That Enable a Healthier World.A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.Position SummaryThe Facilities Engineer is responsible for the compliant operation, maintenance, and continuous improvement of GMP-critical facility programs supporting the manufacture of life-saving medicines within a Contract Development and Manufacturing Organization (CDMO) environment. This role provides ownership of pest control, utilities, and facilities systems across a multi-client manufacturing operation, ensuring continuous inspection readiness, customer compliance, and operational excellence.This role leads maintenance execution, contractor oversight, system shutdowns, and investigations related to GMP systems, while delivering facility services in alignment with client agreements, regulatory expectations, and business objectives. The role serves as a subject matter expert for facility programs during customer audits, regulatory inspections, and technology transfers.Working cross-functionally with Manufacturing, Quality, HSE, Engineering, and client stakeholders, this role drives capital projects, improvement initiatives, and energy conservation programs to ensure the site remains reliable, compliant, and competitive as a CDMO partner.This role requires strong technical expertise, customer-focused communication skills, and the ability to operate effectively in a fast-paced, customer-driven environment. The position operates with significant autonomy and may include direct supervision of employees and contractors within a matrix organization.Duties & ResponsibilitiesCompliance and Inspection ReadinessMaintain GMP facility programs in compliance with local, state, federal, and international regulations.Ensure inspection readiness of facility systems; serve as SME during audits and regulatory inspections.Develop responses and implement corrective actions for deficiencies identified during audits.Maintenance & OperationsOversee preventive maintenance and repairs for building envelope, pest control, electrical, mechanical, HVAC, cooling towers, and security systems.Coordinate system shutdowns and lead investigations related to GMP-critical systems.Manage third-party vendors and contractors to ensure timely and compliant execution of work.Continuous Improvement & ProjectsIdentify and implement energy conservation, cost savings, and reliability improvements.Drive facility-related capital projects (HVAC, clean utilities, infrastructure upgrades) on time, within budget, and in compliance with safety and client requirements.Perform data analysis, root cause investigations, and implement CAPAs for facility programs.Leadership & CollaborationTrain and develop in-house technicians and contractors on SOPs and compliance requirements.Build and sustain strong relationships with internal and external stakeholders, including Manufacturing, Quality, HSE, and regulatory agencies.Communicate effectively with clients and internal teams to support inspection readiness and operational excellence.Education & ExperienceBachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related discipline) or equivalent technical experience required.4–6 years of progressive experience in facilities engineering, maintenance, or utilities management within a GMP-regulated pharmaceutical, biotechnology, or API manufacturing environment preferred.Experience with GMP compliance, facility systems (HVAC, clean utilities, pest control, GMP cleaning), and capital project execution strongly desired.Project management experience (budgeting, scheduling, vendor oversight) is a plus.Familiarity with regulatory requirements (FDA, EMA, OSHA, DEC) and quality systems (change control, investigations, CAPA) required.Knowledge, Skills, AbilitiesTechnical Expertise in facilities engineering, including mechanical, electrical, HVAC, clean utilities, pest control, and GMP cleaning systems.Strong understanding of GMP regulations, quality systems (change control, investigations, CAPA), and applicable standards (FDA, EMA, OSHA, DEC).Project Management Skills: ability to manage budgets, schedules, contractors, and capital projects effectively.Analytical and Problem-Solving Skills for troubleshooting complex facility and utility issues.Ability to interpret technical drawings and documentation and ensure compliance with good engineering practices.Effective Communication Skills, including technical writing and presentation abilities for audits, inspections, and cross-functional collaboration.Customer Service Orientation with the ability to build and maintain strong relationships with internal and external stakeholders.Adaptability and Autonomy: capable of working independently in a fast-paced, matrixed environment with minimal supervision.Computer Proficiency in MS Office Suite and familiarity with CMMS or other maintenance management systems.Physical Capability to perform job-related tasks (lifting, bending, overhead work, confined spaces) and willingness to provide on-call/off-hours support as needed.Physical DemandsThe Facilities Engineer role requires the ability to perform a range of physical activities essential for maintaining and troubleshooting GMP-critical facility systems. These include:Lifting and carrying items up to 50 lbs safely, using proper ergonomic techniques.Bending, stooping, twisting, crouching, squatting, and sitting for extended periods during inspections and maintenance tasks.Walking on level surfaces throughout the facility, including production and utility areas.Repetitive use of arms, hands, and wrists for tool handling, equipment adjustments, and documentation.Grasping and fine manipulation of small components and instruments.Operating vehicles or motorized equipment within facility grounds as required.Kneeling and working in confined spaces during equipment servicing.Reaching and working overhead (above shoulder level) for extended periods when accessing ceiling-mounted systems or piping.Use of foot controls for certain equipment operations.Visual acuity for detailed inspections and troubleshooting (corrective lenses and color vision aids permitted).Crawling in tight spaces during inspections or repairs.Work EnvironmentExposure to temperature variations, noise, and industrial environments typical of GMP manufacturing facilities.Ability to wear personal protective equipment (PPE) including safety glasses, gloves, hearing protection, and respiratory protection as required.Capability to respond to emergency situations and perform tasks under time-sensitive conditions.Supervisory ResponsibilitiesSupervision may include FTEs and contractors; including objective setting for the department.Travel