Manufacturing Technician III - Sterile Filling

Resilience US; Olde West Chester (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Resilience is a technology-focused biomanufacturing company seeking a Manufacturing Technician III to support sterile filling operations on the manufacturing floor. The role requires working in controlled environments and independently operating filling equipment with advanced aseptic techniques and in-process monitoring.

You will mentor Tech II team members, contribute to validation/engineering protocols, and participate in lean initiatives while maintaining high-quality batch records and GMP

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.

Responsibilities

• Independently operate all assigned machinery: service filling machines with materials and ensure 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, including SCADA and HMI entries.
• Work with printing devices, including printing mats.
• Perform cleaning and housekeeping to maintain a cGMP environment.
• Conduct visual and physical checks of in-process and finished materials.
• Demonstrate advanced aseptic technique; lead and participate in media fills and line interventions; monitor environment.
• Assist with preventive maintenance and with validating processes and equipment.
• Support lean activities and process improvements, including 5S and problem solving.
• Perform SAP transactions at an intermediate level.

Skills

pharma manufacturing

cGMP compliance

troubleshooting

team mentoring

data interpretation

English proficiency

Education

High school diploma or equivalent

Tools

SAP

Veeva Vault

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

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.

Job Responsibilities

• 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.

Experience & Education

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.U