Manufacturing Technician III, Mechanic - DAP (Nights)

Job Responsibilities

Operations

• Operate, monitor, and perform maintenance tasks on various packaging equipment.
• Perform technician tasks as required including start-up, equipment operation, manual packaging, 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 escalate concerns.

Maintenance & Technical Support

• 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.

Documentation & Compliance

• 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.

Training & Development

• 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.

Education & Experience

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Physical & Work Environment

• 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 facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
• Ability to pass eye exam during onboarding.

Work Schedule

12-hour night shift – 2/2/3 - 6:00pm to 6:30am. The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.