Facility Engineer

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.