Manufacturing Technician II - Sterile Filling

Operations

• Accountable for the outgoing quality level of inspected product; perform manual visual, cosmetic, and physical inspection of material, promptly escalating concerns to the Lead and Manager/Supervisor.
• Must obtain and maintain visual inspection qualification.
• Operate assigned machinery, including servicing automated inspection equipment, monitoring equipment status, reintroducing materials, manually palletizing inspected materials, and assuring a smooth flow of product.
• Start up equipment, make minor adjustments to machinery, remove jams, and perform minor troubleshooting and assembly/disassembly for cleaning.
• Use material handling equipment such as motorized and manual pallet jacks and non-motorized lifts.
• Perform cleaning, housekeeping and line clearance activities for assigned areas as required to maintain a cGMP environment.
• Apply knowledge of product security controls.
• Perform work in accordance with SOPs, cGMPs, and OSHA-compliant safety procedures, maintaining familiarity with job-related hazards and controls (PPE, ergonomics, LOTO, human/material/waste/chemical handling, and spill control) and area chemical Safety Data Sheets.
• Report all discrepancies to the process facilitator.
• Print SOPs and forms via ECMS.
• Support lean and process-improvement activities, including 5S, problem-solving, and manual tracking of OEE performance data.
• Review operational SOPs, forms, and batch records for accuracy, and suggest process improvements while maintaining quality and cGMP compliance.

Documentation & Compliance

• Perform batch record and GMP documentation entries; maintain records and logs as required, including mathematical computation where needed.
• Perform inventory control, reconciliation, and inventory movements using SAP in a limited role (e.g., moving items between storage locations and goods-issuing to process orders).

Training & Development

• Acquire and maintain all required certifications and qualifications for the assigned work area, including cold room training/access to transfer materials in and out of the cold rooms.
• Cross-train and support other work areas as needed.

Minimum Qualifications

• Prior experience in a regulated manufacturing environment (e.g., pharmaceutical, biotechnology, medical device, or other GMP-regulated industry) is preferred.
• Experience in manufacturing, quality, or visual inspection is highly desirable.
• Ability to effectively read, write, speak, and understand English to accurately interpret and follow Standard Operating Procedures (SOPs), batch records, work instructions, specifications, and other controlled documentation.
• Basic mathematical proficiency, including the ability to perform routine calculations involving weights, measures, percentages, and unit conversions, while accurately documenting inspection and production data.
• Ability to follow written procedures and standardized work with minimal supervision while recognizing abnormal conditions and appropriately escalating quality, safety, equipment, or process concerns.
• Strong attention to detail with the ability to identify product, process, or documentation discrepancies, maintain accurate documentation in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), and consistently adhere to quality standards.
• Basic problem-solving, organizational, and communication skills with the ability to work effectively both independently and collaboratively in a fast-paced manufacturing environment while supporting a culture of safety, quality, and continuous improvement.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 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.
• Experience working in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

Physical & Work Environment

Work is performed in Controlled/Non-Classified and Classified (cleanroom) production areas requiring aseptic gowning. This is primarily a non-Sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP. Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.; ability to pass an eye exam during onboarding. 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.

Work Schedule

12 hour – 2/2/3 Day Shift Schedule - Team A