Manufacturing Technician III, Mechanic - DAP; Nights

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The Manufacturing Technician III, Device Assembly Mechanic reports to a Supervisor/Manager on the Manufacturing floor and supports Device Assembly operations. This position entails setup, operation, monitoring, troubleshooting, and maintenance of device assembly equipment. The Mechanic serves as the first-line technical resource for the device assembly team.

This position will initially be a M-F 8-hour dayshift position. Eventually this position will transition to a night shift 6PM-630AM 2-2-3 rotation.

• Operate, monitor, and perform maintenance tasks on various device assembly equipment.
• Perform technician tasks as required including start-up, equipment operation, and line clearances.
• Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts).
• Monitor material quality of incoming, in-process, and finished materials; promptly escape concerns.

• Act as a first-line technical resource for the team; provide technical support to production technicians.
• Proactively monitor equipment and component conditions; perform preventive maintenance tasks.
• Interpret technical documents including schematics and maintenance manuals to support troubleshooting and repairs.
• Execute protocols as required as part of equipment qualification and process validation work.

• Perform batch records, GMP documentation, and CMMS entries including mathematical computations as required.
• Review process documents such as operational SOPs, PM procedures, forms, and batch records for accuracy.
• Support lean activities and process improvement work including 5S and problem-solving.

• Act as a certified OJT trainer on assigned equipment or process tasks.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Attend and actively participate in daily tier meetings.

• Prior experience with equipment maintenance, troubleshooting, or preventive maintenance tasks in a manufacturing setting.
• Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Strong working knowledge of cGMP regulations, including documentation practices, deviation reporting, and data integrity principles.
• Demonstrated mechanical and technical aptitude, including the ability to interpret schematics and maintenance manuals.
• Proven ability to independently execute procedures and troubleshoot routine equipment and process issues.
• Demonstrated ability to independently review and ensure accuracy of batch records, CMMS entries, and controlled documentation.
• Mathematical skills sufficient to perform routine production and maintenance calculations and verify entries in batch records and CMMS.
• Ability to effectively read, write, speak, and understand English to interpret technical documents and communicate cross-functionally.
• Ability to work effectively as part of a team in a fast-paced production environment.

• High school graduate, vocational school graduate, or equivalent.
• 2+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Experience in a lean manufacturing environment.
• Prior experience as an equipment OJT trainer.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of…