ObjectiveThe Manufacturing Engineer is responsible for the lifecycle management of GMP production, laboratory, and safety equipment within a newly constructed radiopharmaceutical manufacturing facility. This role supports facility startup activities by assisting with commissioning, qualification, startup, and turnover of manufacturing and laboratory equipment while establishing long-term maintenance, calibration, and reliability programs.
The Manufacturing Engineer will develop and implement preventive maintenance and calibration strategies utilizing the site's Computerized Maintenance Management System (CMMS), collaborate with equipment manufacturers and service providers, and ensure equipment remains in a validated state throughout its operational lifecycle. This position works closely with Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Radiation Safety, and Environmental Health & Safety to ensure equipment reliability, regulatory compliance, and uninterrupted manufacturing operations.
Essential Functions- Owns, supports, and performs routine preventative maintenance on production, quality control, and safety equipment (isolators, synthesis modules, glove testers, VHPs, HPLCs, gamma counters, fume hoods, biosafety cabinets, area monitors, etc).
- Troubleshoots problems associated with equipment performance, maintenance, calibration and commissioning/qualification.
- Responds to production-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 cleanroom equipment relocation, renovations, and continuous improvement activities as requested by various departments.
- Acts as a point of contact for external service providers for routine work (preventative maintenance, calibration programs, vendor provided qualification) 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.
Education/Experience- 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
Knowledge/Skill/Ability- 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 EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- 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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 
