Manufacturing Technician II - Sterile Filling

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The Manufacturing Technician II reports to a Supervisor/Manager on the Manufacturing floor, supporting Filling operations. This position requires working in various Controlled/Non-Classified and Classified areas.

• Perform the duties of operating 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.
• Understand aseptic behaviors; participate in media fills, including line interventions; maintain basic knowledge of viable and non-viable monitoring equipment.
• 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.
• Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance.

• Perform batch record and GMP documentation entries; maintain records and logs as required, including mathematical computation where needed.
• Perform inventory control and reconciliation activities using SAP in a limited role.

• Acquire and maintain all required certifications and qualifications for the assigned work area, including aseptic gowning qualification.
• 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 effectively read, write, speak, and understand English to interpret SOPs, batch records, and work instructions.
• 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 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.
• 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.

Work is performed in Controlled/Non-Classified and Classified (cleanroom) production areas requiring aseptic gowning.

This is primarily a…