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.

The 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.

• Maintain 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.

• Oversee 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.
• Identify 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.
• Train 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.

• Bachelor’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.

• Technical expertise in facilities engineering, including mechanical, electrical, HVAC, clean utilities, pest control, and GMP…