Manufacturing Technician II - Sterile Filling (Day Shift)

Job Responsibilities

Operations

• 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.

Documentation & 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.

Training & Development

• 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.

Education & Experience

Minimum Qualifications

• 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.

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. 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. All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. Ability to pass eye exam during onboarding.