Major accountabilities:
- Adhere to Quality policies/procedures to ensure products are safe, pure, effective, and high quality.
- Perform corrective and preventative maintenance and repair on production equipment, lab equipment, and building management systems.
- Troubleshoot and repair process equipment (e.g., containment isolators, filling line equipment/utilities) using mechanical, electrical, pneumatics, motors/pumps, vacuum, HVAC, control systems, and compressed gases.
- Interpret P&IDs, layouts, wiring diagrams, and specifications.
- Support 24x7 site operations after startup.
- Write/revise operational, training, and maintenance procedures; provide radiation safety program support (calibrate and ensure functionality of radiation detection equipment).
- Complete and document work orders in CMMS; supply spare parts technical data.
- Support customer responsiveness; perform startup/commissioning.
- Support investigations/deviations and provide data for timely CAPA closure.
- Perform cleanroom preventative/corrective maintenance; complete cGMP documentation; oversee/train junior technicians.
Minimum requirements:
- High School diploma/equivalent (Bachelorβs preferred).
- 1+ year hands-on plant maintenance experience in a regulated GMP environment.
- Preferred: aseptic fill/finish and/or radio pharmacy; pharmaceutical/medical device experience; training in radioactive/hazardous materials.
- Knowledge of applicable OSHA/DEA/FDA/HS&E and other quality/regulatory requirements.
- Team communication; MS Office; Building Management Systems; CMMS.
- Lift up to 50 lbs; protective clothing (respiratory protection, confined space, cleanroom).
- Flexible for nights/weekends/holidays.