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Facility Engineer

Branchburg Township, New Jersey, United States · On-site

$100k–$120k/yr

Senior

The Facility Engineer will play a critical role in the long-term operation and optimization of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will identify process and facility improvement…

Skills: Pharmaceutical System Design, Project Management, Root Cause Analysis, Aseptic Manufacturing, Environmental Controls

Serovia logo

Facility Engineer

Serovia

Branchburg Township, New Jersey, United States • On-site

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Senior

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  • $100k–$120k/yr
  • Full-time
  • bachelor degree
  • Posted 38d ago
  • ~40 hrs/week

Responsibilities

The Facility Engineer is responsible for the operation, optimization, and compliance of a sterile injectable IV bag manufacturing facility. This includes leading the design and implementation of critical utility systems, managing preventative maintenance, and ensuring adherence to cGMP standards.

Requirements

Requires a Bachelor's degree in Chemical, Mechanical, or Electrical Engineering with over 7 years of experience in pharmaceutical facility engineering. Candidates must possess strong technical knowledge of HVAC for aseptic manufacturing and a solid understanding of FDA cGMP regulations.

Full job description

The Facility Engineer will play a critical role in the long-term operation and optimization of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will identify process and facility improvements and will then lead the implementation of these programs to improve and optimize process and facility systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing. The Facility Engineer will collaborate with cross-functional teams ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.

 

Key Responsibilities:

  1. Identify system improvements, develop potential solutions with costing, impact and timing.  Recommend to management the best option and justification for investment. 
  2. Lead the design review, specification development, and technical oversight of systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.
  3. Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.
  4. Oversee project execution, installation, commissioning, and qualification of utility and infrastructure systems, ensuring timely, compliant project execution.
  5. Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.
  6. Promote and ensure adherence to safety protocols and safe work practices.
  7. Perform risk assessments for engineering and maintenance activities.
  8. Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.
  9. Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.
  10. Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.
  11. Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services.
  12. Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.
  13. Ensure ongoing regulatory inspection readiness and serve as SME for various systems during audits and inspections.

 

Qualifications / Experience:

  • Bachelor’s degree in chemical, mechanical, or Electrical Engineering.
  • 7+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering or relevant experience with a facility design firm.
  • Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.
  • Direct experience with construction, commissioning, and qualification highly desirable.
  • Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.

 

Skills / Competencies:

  • Experience in pharmaceutical system design, commissioning, and lifecycle maintenance.
  • Strong project management and contractor/vendor coordination capabilities.
  • Excellent problem-solving and root cause analysis skills.
  • Strong understanding of aseptic manufacturing facility requirements and environmental controls.
  • Effective communication and cross-functional collaboration skills.
  • High attention to detail, safety, and compliance.
  • Ability to thrive in a dynamic greenfield/startup environment.

Related keywords

cGMPFDAUSPHVACCleanroomsWFIClean SteamIQ/OQ/PQAseptic ProcessingSterile ManufacturingCAPAEnvironmental MonitoringBuilding AutomationEnergy ManagementEHSCommissioning

About Serovia

LinkedIn

Medicine that listens

Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2025
Headquarters
Bangalore
LinkedIn followers
444

Serovia is a specialty injectable platform committed to delivering better healthcare outcomes through a focused portfolio and by partnering with leading firms for new technologies. As part of the Tenshi Group, Serovia brings together value-add expertise, a strong governance backbone, and deep understanding of global healthcare needs. We are building a state-of-the-art injectable manufacturing facility in the United States, reflecting our commitment to quality, compliance, and sustainable growth. Backed by the same investors who support OneSource, Strides and other successful ventures, Serovia concentrates on complex, differentiated, and first-to-market opportunities, including select 505(b)(2) NDA programs. Our goal is to build trusted partnerships and create lasting value for hospitals, caregivers, and patients through innovation, disciplined execution, and market insight. At the heart of Serovia’s journey is our human capital vision, shared across the Tenshi Group: to attract, develop, and empower diverse talent through continuous learning, cross-entity collaboration, and a culture that blends science with purpose. We welcome collaboration with commercial partners, customers, and professionals who share our ambition to shape the future of specialty injectables. For collaborations and professional engagement, please contact: • Chris Eckerle, Site Leader, Branchburg Site, United States | [email protected] • Kalpesh Vohra, Head - Group HR CoE, HQ, India | [email protected]

Offices: Bangalore, IN · 211 Evans Way, Branchburg, New Jersey 08876, US

PharmaceuticalsComplex Specialty InjectablesCare Led InnovationAdvanced ManufacturingCollaborative EcosystemStrategic Market Focusand Made-in-US
View all jobs at Serovia

About Serovia

LinkedIn

Medicine that listens

Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2025
Headquarters
Bangalore
LinkedIn followers
444

Serovia is a specialty injectable platform committed to delivering better healthcare outcomes through a focused portfolio and by partnering with leading firms for new technologies. As part of the Tenshi Group, Serovia brings together value-add expertise, a strong governance backbone, and deep understanding of global healthcare needs. We are building a state-of-the-art injectable manufacturing facility in the United States, reflecting our commitment to quality, compliance, and sustainable growth. Backed by the same investors who support OneSource, Strides and other successful ventures, Serovia concentrates on complex, differentiated, and first-to-market opportunities, including select 505(b)(2) NDA programs. Our goal is to build trusted partnerships and create lasting value for hospitals, caregivers, and patients through innovation, disciplined execution, and market insight. At the heart of Serovia’s journey is our human capital vision, shared across the Tenshi Group: to attract, develop, and empower diverse talent through continuous learning, cross-entity collaboration, and a culture that blends science with purpose. We welcome collaboration with commercial partners, customers, and professionals who share our ambition to shape the future of specialty injectables. For collaborations and professional engagement, please contact: • Chris Eckerle, Site Leader, Branchburg Site, United States | [email protected] • Kalpesh Vohra, Head - Group HR CoE, HQ, India | [email protected]

Offices: Bangalore, IN · 211 Evans Way, Branchburg, New Jersey 08876, US

PharmaceuticalsComplex Specialty InjectablesCare Led InnovationAdvanced ManufacturingCollaborative EcosystemStrategic Market Focusand Made-in-US
View all jobs at Serovia

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