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 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.

Duties & Responsibilities

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 a matrixed organization, balancing desk-based engineering work with hands-on field support.

Education & Experience

Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline) required; Master’s degree preferred.
4+ years of progressive engineering experience in a GMP-regulated manufacturing environment.
Demonstrated experience serving as a technical SME for HVAC systems, utilities, and/or classified manufacturing environments.
Experience leading capital projects, contractor oversight, and regulatory inspections or customer audits.

Knowledge, Skills, Abilities

Strong technical expertise in facilities engineering, utilities, and building systems within regulated manufacturing environments.
Demonstrated ability to operate effectively in a fast-paced, customer-driven organization while maintaining a high level of compliance and service.
Ability to work with significant autonomy and exercise sound judgment; may include direct supervision and coordination of employees and contractors within a matrix organization.
Proven capability to safely manage projects on schedule and within budget using contractors and/or in-house technicians.
Skilled in scoping projects based on client requirements, developing budget estimates, and preparing and submitting capital project requests.
Solid understanding of facilities and building maintenance activities, including utilities infrastructure and critical systems.
Working knowledge of applicable regulatory, environmental, GMP/GLP, OSHA, and safety requirements for pharmaceutical, biologics, and laboratory environments.
Familiarity with the design, construction, operation, and maintenance of laboratory, office, manufacturing, and utility plant facilities.
Strong analytical, logical, and systematic troubleshooting skills, particularly for HVAC, utilities, and manufacturing support systems.
Experience supporting maintenance, operations, utilities, and manufacturing equipment in a regulated environment.
Thorough understanding of HVAC-R systems for cleanroom and classified environments and their impact on product quality and compliance.
Demonstrated ability to work independently as a self-starter while also collaborating effectively across functions and organizational levels.
Strong interpersonal and customer-focused communication skills, with the ability to build productive relationships with internal and external stakeholders.
Excellent organizational, documentation, and time-management skills, with the ability to manage multiple priorities simultaneously.
Strong written and verbal communication skills, including the ability to clearly convey technical information to diverse audiences.
Proficiency with computerized maintenance management systems (CMMS); experience with Maximo or similar systems preferred.

Physical Demands

The position frequently requires bending, stooping, twisting, crouching or squatting, sitting, walking on level surfaces, and performing repetitive movements involving the arms, hands, and wrists. It also involves grasping, fine manipulation, and operating vehicles on a regular basis. Occasionally, the role may require kneeling, lifting items up to 50 pounds, reaching and working overhead at shoulder level, using foot controls, maintaining vision acuity (with color correction allowed), and crawling.

Work Environment

The position is predominantly during normal work hours, but on occasion requires flexibility to work outside normal business hours, be on-call, and be available for off-shifts. Work is primarily performed indoors, both independently and in collaboration with others on a frequent basis. Occasionally, duties may involve outdoor work and exposure to noise levels equal to or greater than 85 dBA, with hearing protection required. Infrequent conditions include exposure to extreme heat, confined spaces, cramped quarters, heights, dust, mist, fumes, wet or damp surfaces, and chemicals.

Supervisory Responsibilities

Supervision may include FTEs and contractors; including objective setting for the department

Travel

<5% Travel Required

Target Bonus

10%

Work Location:

East Syracuse, NY

New York Pay Range: $76,000 USD - $113,000 USD

We are an Equal Employment Opportunity (“EEO”) Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!

LOTTE Biologics

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