Plant Engineer, HVAC & Utilities

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 Plant Engineer, HVAC & Utilities is responsible for the compliant design, operation, maintenance, and continuous improvement of HVAC, classified room environments, Building Automation Systems, and other critical utilities supporting the manufacture of life‑saving medicines within a Contract Development and Manufacturing Organization (CDMO) environment. This role provides ownership of HVAC‑R, clean room environments, and support utility systems across a multi‑client manufacturing operation, ensuring continuous inspection readiness, customer compliance, and operational excellence.

• Lead execution of maintenance activities for HVAC systems, classified environments, and related utilities, including contractor oversight, room certification oversight, and system startups and shutdowns.
• Serve as the primary Subject Matter Expert (SME) for HVAC systems and classified manufacturing environments during customer audits, regulatory inspections, and technology transfers; act as backup SME for other critical utility systems.
• Ensure compliant operation of facilities and utilities in alignment with client agreements, regulatory requirements, LOTTE policies, and business objectives.
• Partner cross‑functionally with Manufacturing, Quality, HSE, Engineering, and client stakeholders to support compliance activities, maintenance execution, capital projects, change controls, and continuous improvement initiatives.
• Develop, plan, and implement facility‑related capital projects, including HVAC, utilities, refrigeration systems, building infrastructure, obsolescence remediation, and continuous improvement projects, ensuring safe execution, schedule adherence, budget control, and proper documentation.
• Oversee maintenance execution and coordinate planned and unplanned system shutdowns to minimize manufacturing disruption.
• Lead and support investigations related to HVAC systems, classified room environments, and utility failures; develop and implement corrective and preventive actions.
• Provide technical guidance and hands‑on support to maintenance technicians, operations personnel, contractors, and outside service providers.
• Issue, review, and contribute to safety permits and Job Hazard Analyses (JHAs); provide safety leadership to employees and contractors with safety as the top priority.
• Review and approve technical documentation, drawings, specifications, and procedures to ensure accuracy, compliance, and alignment with current industry standards and best practices.
• Respond to unplanned outages and equipment failures, leveraging internal teams and integrated facilities management providers to restore operations efficiently.
• Apply modern reliability and maintenance concepts to prevent failures and improve system performance; identify opportunities for continuous improvement, energy conservation, and cost savings.
• Develop, revise, and maintain SOPs governing operation and maintenance of HVAC and utility systems; train in‑house technicians and contractors as required.
• Maintain inspection readiness for regulatory and internal audits; interact directly with regulatory authorities, auditors, and client representatives, and develop corrective action plans for identified deficiencies.
• Create and implement change controls for HVAC and utility systems in compliance with GMP and regulatory requirements.
• Coordinate projects and activities with PM/PdM, Calibration, Utilities, and Maintenance & Reliability teams from initiation through closure to ensure proper design, construction, validation, and documentation.
• Provide technical support to Biologics and ADC manufacturing operations and ensure compliance with applicable directives, standards, and regulations for regulated facilities.
• Develop and…