Manufacturing Technician III - Sterile Filling; Nights

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The Manufacturing Technician III reports to a Supervisor/Manager on the Manufacturing floor, supporting Filling (Sterile) operations. This position requires working in Controlled/Non-Classified and Classified areas. The Technician independently operates filling equipment, demonstrates advanced aseptic technique, performs in-process monitoring, and mentors Tech II team members.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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…