Manufacturing Technician II - Inspection; PFS Nights

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The Manufacturing Technician II reports to a Supervisor/Manager, Manufacturing and works in Controlled/Non-Classified areas, supporting Inspection operations. The Technician performs a variety of tasks including operating inspection equipment, performing visual/cosmetic/physical inspection, line clearances, OEE data collection, and completing batch record entries per cGMPs.

• Perform the duties of operating assigned inspection machinery: service automated inspection equipment, monitor equipment status, reintroduce materials, manually palletize inspected materials, and ensure smooth product flow.
• Perform manual visual, cosmetic, and physical inspection of material; promptly escalates concerns to Lead and Supervisor/Manager as needed.
• Start-up equipment, make minor adjustments, remove jams, perform minor troubleshooting, and perform minor assembly/disassembly for cleaning purposes.
• Use material handling equipment such as motorized and manual pallet jacks and non-motorized lifts.
• Transfer materials in and out of cold rooms as needed.
• Perform cleaning, housekeeping, and line clearance activities for assigned areas to maintain a cGMP environment.
• Support lean activities and process improvement work including 5S and problem-solving.
• Identify and propose process improvements while maintaining quality and cGMP compliance.
• Perform inventory control using SAP.

• Perform batch record and GMP documentation entries, including mathematical computations; maintain records and logs as required.
• Access and print SOPs and forms via ECMS as required.
• Use process documents including SOPs, forms, and batch records to guide work; report discrepancies to supervisor.
• Follow job-related safety procedures including PPEs, LOTO, ergonomics, material handling, chemical/waste/spill controls, and human safety.

• Acquire and maintain all required certifications and qualifications for the assigned work area, including visual inspection qualification and cold room training.
• Cross-train and support other work areas as needed.
• Attend and actively participate in daily Tier meetings.

• Prior experience in a regulated manufacturing environment.
• Ability to detect visual defects and perform repetitive inspection tasks with sustained accuracy.
• Working knowledge of product security controls and material handling equipment.
• Demonstrated documentation and data entry skills, including accurate completion of batch records and logbooks.
• Basic mathematical skills, including the ability to perform routine calculations (e.g., weights, measures, conversions).
• Ability to effectively read, write, speak, and understand English to interpret SOPs, batch records, and work instructions.
• Ability to follow written procedures and work instructions with minimal supervision, escalating issues as needed.
• Basic problem-solving skills and the ability to identify deviations or inconsistencies in processes or documentation.
• Ability to work effectively as part of a team in a fast-paced production environment.

• High school graduate, vocational school graduate, or equivalent.
• Prior inspection experience.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations.
• Familiarity with defect classification, batch documentation, and GDP/GMP practices.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.
• Experience working in a lean manufacturing 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…