Facility Engineer

• The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.
• The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.

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

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

• Expertise Experience in facility 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.

WhiteCrow Research