Plant Engineer, HVAC & Utilities

Position Summary

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 implement performance targets to promote quality, safety, reliability, and customer satisfaction.
• Build and maintain strong working relationships with internal and external stakeholders, including Manufacturing, Quality, HSE, Engineering, service providers, and regulatory agencies; periodically assess service levels and strive to exceed expectations.
• Work independently on routine and recurring assignments within…