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.

• 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.

• 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…