Facilites Engineer

Objective: The Facilities Engineer is responsible for supporting the startup, commissioning, qualification, maintenance, and continuous operation of all facility infrastructure supporting GMP radiopharmaceutical manufacturing. As part of a newly constructed manufacturing site, this role will play a key role in transitioning facility systems from construction through commissioning and into routine commercial operations.

About the role

The Facilities Engineer will work closely with Engineering, Validation, Quality Assurance, Operations, EHS, and external vendors to establish robust preventive maintenance and calibration programs, develop maintenance strategies within the Computerized Maintenance Management System (CMMS), support commissioning and qualification activities, and ensure facility utilities remain reliable, compliant, and inspection-ready. The successful candidate will drive equipment reliability while maintaining compliance with FDA, cGMP, radiation safety, and company engineering standards.

Responsibilities

• Owns, supports, and performs routine preventative maintenance on facilities equipment (HVAC, BAS/BMS, Cleanroom EMS, Boilers, Chillers, Air compressors, Technical gasses, emergency generators, UPSs, Electrical, Lighting, Fire alarm/suppression, and building infrastructure).
• Troubleshoots problems associated with equipment performance, maintenance, calibration and commissioning/qualification.
• Responds to facility-related alarms and acknowledges, troubleshoots, and rectifies the alarm situation as needed or with assistance from supervisors.
• Manages maintenance work requests using a CMMS, including accurate work performance logs, material usage, and labor hours.
• Authors and executes Change Controls, commissioning/validation protocols, and technical documentation in alignment with GMP requirements.
• Supports investigations and root-cause analyses for equipment- or facility-related deviations or issues.
• Effectively participates in a project or major repair team. Establishes personal objectives which complement group and organizational goals.
• Provides support in fault-finding and root-cause analysis investigations as a developing technical resource.
• Assist with furniture moves and conference room set ups as requested by various departments.
• Acts as a point of contact for external service providers for routine work (maintenance, pest control, landscaping) and for on-demand work (breakdowns, repairs).
• Focused on continuous skill development in the areas of automation, electrical, mechanical troubleshooting and utilities operation.
• Actively applies and promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.

Requirements

• Bachelor’s degree in an engineering/technical discipline, preferably Mechanical, Electrical or Chemical Engineering, with 5 years of facilities related experience.
• 5 - 8 years of relevant facilities maintenance experience in a cGMP facility, such as a setup mechanic, will be considered in lieu of technical education.
• Working experience in the use and application of standard hand and power tools in the performance of maintenance-related work.
• A working knowledge of Good Manufacturing Practices (GMP).
• Basic electrical troubleshooting and repair in the performance of maintenance-related work.
• Basic carpentry repair and painting in the performance of maintenance-related work.

Skills

• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external.
• Working knowledge of cGMP requirements and maintenance documentation practices.
• Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity.
• Ability to use standard hand/power tools and perform basic electrical, carpentry, or mechanical tasks.
• Valid driver’s license; ability to lift up to 50 lbs.; willingness to work evenings, weekends, and holidays as needed.
• Respirator fit test required.
• Ability to maintain focus on a complex task for 4-6 hours at a time.
• Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided. Takes ownership and accountability for assigned work and associated documentation.

Work Environment

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.