Plant Engineer, HVAC & Utilities jobs in United States
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LOTTE Biologics · 1 day ago

Plant Engineer, HVAC & Utilities

LOTTE Biologics is a new company dedicated to delivering therapies that enable a healthier world. The Plant Engineer, HVAC & Utilities is responsible for the design, operation, maintenance, and continuous improvement of HVAC systems and utilities in a manufacturing environment, ensuring compliance and operational excellence.

AnalyticsBiotechnologyManufacturing
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H1B Sponsor Likelynote

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

Qualification

HVAC systemsGMP-regulated environmentFacilities engineeringCapital project managementBuilding Automation SystemsUtilities infrastructureRegulatory complianceTechnical documentationAnalytical skillsSafety leadershipTroubleshooting skillsProject scopingInterpersonal skillsTime-management skillsCommunication skillsTeam collaborationCustomer-focusedSelf-starter

Required

Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or related discipline) required
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
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)

Preferred

Master's degree preferred
Experience with Maximo or similar systems preferred

Benefits

Target Bonus 10%

Company

LOTTE Biologics

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LOTTE Biologics offers end-to-end CDMO services for biopharmaceutical manufacturing, aiming for global top 10 status.

H1B Sponsorship

LOTTE Biologics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)

Funding

Current Stage
Late Stage

Leadership Team

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Alex Budwey SHRM - CP
Human Resources Business Partner
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Company data provided by crunchbase