Manufacturing Technician III - Sterile Filling (Day Shift)

Operations

• Independently perform the duties of operating all assigned machinery: servicing filling machines with materials, removing finished materials from machine tables, and assuring smooth product flow.
• Assemble, disassemble, operate, and sanitize various Filling equipment.
• Perform and execute filter integrity testing as needed per SOP.
• Start-up equipment and make minor adjustments as needed.
• Enter data online as required, including SCADA and HMI entries.
• Work with various printing devices, including printing mats.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Perform visual and physical checks of in-process and finished materials as requested.
• Demonstrate advanced aseptic technique; lead and participate in media fills, including line interventions; apply working knowledge of viable and non-viable environmental monitoring.
• Assist mechanical staff with preventive maintenance procedures, as required.
• Assist with executing Validation/Engineering protocols for processes and equipment.
• Support lean activities and process improvement work, such as performing 5S and participating in problem-solving.
• Perform SAP transactions as required at an intermediate level of knowledge.

Documentation & Compliance

• Complete batch record and GMP documentation entries; independently review own documentation for accuracy before submission.
• Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance.

Training & Development

• Act as a certified OJT trainer on assigned equipment and process tasks; train and evaluate Tech II team members.
• Maintain all required certifications and qualifications for the assigned work area.
• Cross-train and support other work areas as needed.
• Attend and actively participate in daily tier meetings.

Minimum Qualifications

• Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including independent execution of filling procedures.
• Strong working knowledge of cGMP regulations, including deviation reporting, change control, and data integrity principles.
• Proven ability to independently execute complex procedures and troubleshoot routine process or equipment issues.
• Ability to effectively read, write, speak, and understand English to interpret technical documents and clearly communicate cross-functionally.
• High level of attention to detail with demonstrated accuracy in completing and reviewing batch records and controlled documentation.
• Proficient mathematical and analytical skills, including performing calculations related to manufacturing processes and verifying results.
• Experience mentoring or training technicians and supporting onboarding of new team members.
• Ability to identify process improvements and contribute to continuous improvement initiatives.
• Strong organizational skills and the ability to prioritize tasks while maintaining compliance and production timelines.
• 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.
• Prior aseptic manufacturing experience.
• 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. 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. Ability to pass eye exam during onboarding.

Work Schedule

12 hour -2/2/3 Nightshift