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WhiteCrow Research

Facility Engineer

WhiteCrow Research, Branchburg Township, New Jersey, United States

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Facility Engineer – WhiteCrow Research WhiteCrow Research, a global talent research and insight specialist, is seeking an experienced Facility Engineer to lead the greenfield design, construction, startup, and long‑term operation of a state‑of‑the‑art sterile injectable IV bag manufacturing facility.

Responsibilities

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.

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.

Qualifications

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 in facility system design, commissioning, and lifecycle maintenance.

Strong project management and contractor/vendor coordination capabilities.

Excellent problem‑solving and root cause analysis skills.

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 is an equal opportunity employer. All qualified applicants, including persons with disabilities and veterans, will receive consideration for employment.

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