LOTTE Biologics
We are
LOTTE BIOLOGICS ! Delivering therapies that enable a healthier world. With an 80‑year legacy of innovation, our mission is to be the most trusted partner in the industry, upholding high quality standards.
Position Summary The Plant Engineer, HVAC & Utilities owns the compliant design, operation, maintenance and continuous improvement of HVAC, clean‑room environments, Building Automation Systems and other critical utilities supporting life‑saving medicines within a CDMO environment. Responsibilities include ensuring continuous inspection readiness, customer compliance and operational excellence across a multi‑client manufacturing operation.
Duties & Responsibilities
Lead execution of maintenance activities for HVAC systems, classified environments and related utilities, including contractor oversight, room certification and system startups/shutdowns.
Serve as the primary SME for HVAC systems during audits, 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 and LOTTE policies.
Partner cross‑functionally with Manufacturing, Quality, HSE, Engineering and client stakeholders on compliance activities, maintenance execution, capital projects, change controls and continuous improvement initiatives.
Develop, plan and implement capital projects (HVAC, utilities, refrigeration, obsolescence remediation) 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 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 and contractors.
Issue safety permits and JHAs; lead safety for employees and contractors.
Review and approve technical documentation, drawings, specifications and procedures.
Respond to unplanned outages and equipment failures, leveraging internal teams and integrated facilities management providers to restore operations efficiently.
Apply reliability concepts to prevent failures, improve system performance and identify opportunities for energy conservation and cost savings.
Develop, revise and maintain SOPs governing HVAC and utility operation and maintenance; train in‑house technicians and contractors as required.
Maintain inspection readiness for regulatory and internal audits; 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 with PM/PdM, Calibration, Utilities, 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 performance targets to promote quality, safety, reliability and customer satisfaction.
Build strong relationships with internal and external stakeholders, including Manufacturing, Quality, HSE, Engineering, service providers and regulatory agencies.
Work independently on routine and recurring assignments within a matrixed organization.
Education & Experience
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical or related discipline) required; Master’s preferred.
4+ years of progressive engineering experience in a GMP‑regulated manufacturing environment.
SMD supervisor 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.
Demated ability to operate effectively in a fast‑paced, customer‑driven organization while maintaining compliance and service.
Independence and sound judgment; may include direct supervision and coordination of employees and contractors within a matrix organization.
Proven ability to safely manage projects on schedule and within budget using contractors and/or in‑house technicians.
Skilled in scoping projects, developing budget estimates and preparing capital project requests.
Solid understanding of utilities infrastructure and critical systems.
Working knowledge of applicable regulatory, environmental, GMP/GLP, OSHA and safety requirements.
Familiarity with the design, construction, operation and maintenance of laboratory, office, manufacturing and utility plant facilities.
Strong analytical, troubleshooting and systematic skills 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.
Strong interpersonal, customer‑focused communication skills and ability to build productive relationships.
Excellent organization, documentation and time‑management skills; ability to manage multiple priorities.
Strong written and verbal communication skills; ability to convey technical information to diverse audiences.
Proficiency with CMMS (Maximo or similar) preferred.
Physical Demands Frequent bending, stooping, twisting, crouching or squatting; sitting, walking on level surfaces and repetitive arm and wrist movements. Occasionally kneeling, lifting up to 50 pounds, reaching overhead at shoulder level, using foot controls and maintaining vision acuity (color correction allowed). Crawling may be required.
Work Environment Primarily normal work hours; may require flexibility for outside hours, on‑call and off‑shifts. Mostly indoors; occasional outdoor work and noise levels ≥85 dBA with hearing protection required. Infrequent 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; objective setting for the department.
Travel 5% Travel Required.
Target Bonus 10%.
Work Location East Syracuse, NY.
Equal Employment Opportunity 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, then please apply today!
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LOTTE BIOLOGICS ! Delivering therapies that enable a healthier world. With an 80‑year legacy of innovation, our mission is to be the most trusted partner in the industry, upholding high quality standards.
Position Summary The Plant Engineer, HVAC & Utilities owns the compliant design, operation, maintenance and continuous improvement of HVAC, clean‑room environments, Building Automation Systems and other critical utilities supporting life‑saving medicines within a CDMO environment. Responsibilities include ensuring continuous inspection readiness, customer compliance and operational excellence across a multi‑client manufacturing operation.
Duties & Responsibilities
Lead execution of maintenance activities for HVAC systems, classified environments and related utilities, including contractor oversight, room certification and system startups/shutdowns.
Serve as the primary SME for HVAC systems during audits, 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 and LOTTE policies.
Partner cross‑functionally with Manufacturing, Quality, HSE, Engineering and client stakeholders on compliance activities, maintenance execution, capital projects, change controls and continuous improvement initiatives.
Develop, plan and implement capital projects (HVAC, utilities, refrigeration, obsolescence remediation) 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 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 and contractors.
Issue safety permits and JHAs; lead safety for employees and contractors.
Review and approve technical documentation, drawings, specifications and procedures.
Respond to unplanned outages and equipment failures, leveraging internal teams and integrated facilities management providers to restore operations efficiently.
Apply reliability concepts to prevent failures, improve system performance and identify opportunities for energy conservation and cost savings.
Develop, revise and maintain SOPs governing HVAC and utility operation and maintenance; train in‑house technicians and contractors as required.
Maintain inspection readiness for regulatory and internal audits; 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 with PM/PdM, Calibration, Utilities, 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 performance targets to promote quality, safety, reliability and customer satisfaction.
Build strong relationships with internal and external stakeholders, including Manufacturing, Quality, HSE, Engineering, service providers and regulatory agencies.
Work independently on routine and recurring assignments within a matrixed organization.
Education & Experience
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical or related discipline) required; Master’s preferred.
4+ years of progressive engineering experience in a GMP‑regulated manufacturing environment.
SMD supervisor 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.
Demated ability to operate effectively in a fast‑paced, customer‑driven organization while maintaining compliance and service.
Independence and sound judgment; may include direct supervision and coordination of employees and contractors within a matrix organization.
Proven ability to safely manage projects on schedule and within budget using contractors and/or in‑house technicians.
Skilled in scoping projects, developing budget estimates and preparing capital project requests.
Solid understanding of utilities infrastructure and critical systems.
Working knowledge of applicable regulatory, environmental, GMP/GLP, OSHA and safety requirements.
Familiarity with the design, construction, operation and maintenance of laboratory, office, manufacturing and utility plant facilities.
Strong analytical, troubleshooting and systematic skills 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.
Strong interpersonal, customer‑focused communication skills and ability to build productive relationships.
Excellent organization, documentation and time‑management skills; ability to manage multiple priorities.
Strong written and verbal communication skills; ability to convey technical information to diverse audiences.
Proficiency with CMMS (Maximo or similar) preferred.
Physical Demands Frequent bending, stooping, twisting, crouching or squatting; sitting, walking on level surfaces and repetitive arm and wrist movements. Occasionally kneeling, lifting up to 50 pounds, reaching overhead at shoulder level, using foot controls and maintaining vision acuity (color correction allowed). Crawling may be required.
Work Environment Primarily normal work hours; may require flexibility for outside hours, on‑call and off‑shifts. Mostly indoors; occasional outdoor work and noise levels ≥85 dBA with hearing protection required. Infrequent 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; objective setting for the department.
Travel 5% Travel Required.
Target Bonus 10%.
Work Location East Syracuse, NY.
Equal Employment Opportunity 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, then please apply today!
#J-18808-Ljbffr