Responsibilities:
- Perform corrective and preventative maintenance and support services for building equipment and all equipment at a GMP Radioligand Therapies Production Facility to ensure reliable, efficient, sustained operation.
- Perform maintenance repairs on production equipment, lab equipment, and building management systems.
- Troubleshoot and repair process equipment (e.g., containment isolator systems, filling line equipment and utility connections) including mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, with little to no supervision.
- Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications.
- Support 24x7 site-based operations after startup.
- Write/revise operational procedures, training documents, and maintenance procedures.
- Support radiation safety program activities; calibrate and ensure functionality of radiation detection equipment.
- Complete and document equipment work orders in the system (CMMS).
- Provide technical data for securing spare parts.
- Provide responsive customer support.
- Perform startup/commissioning activities as required.
- Support investigations/deviations and provide data for CAPA closure.
- Perform preventative and corrective maintenance in a cleanroom environment; complete cGMP documentation.
- Oversee work and train less experienced technicians/new technicians.
Minimum Requirements:
- High School diploma or equivalent required; Bachelorβs degree preferred.
- 1+ years of hands-on plant maintenance experience in a regulated GMP environment.
- Must adhere to applicable procedures, company policies, and quality/regulatory requirements (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
- Team experience with excellent communication and organizational skills.
- Proficient with MS Office, Building Management Systems, and CMMS (or similar).
- Ability to climb ladders and lift up to 50 lbs.
- Wear/work in protective clothing, including respiratory protection, confined space entry, and cleanroom environments.
- Flexible to work nights, weekends, and holidays as required.
Preferred:
- Previous aseptic fill/finish and/or radio pharmacy experience.
- Previous pharmaceutical or medical device experience.
- Training in radioactive or hazardous materials environments.
Benefits (as stated):
- Performance-based cash incentive; eligibility for annual equity awards (role-dependent).
- Comprehensive benefits package (health, life, disability); 401(k) with company contribution and match; time off including vacation, personal days, holidays, and other leaves.