Manufacturing Technician III - Sterile Filling

Resilience•West Chester, OH

6d•Onsite

About The Position

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. 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.

Requirements

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.
Ability to pass eye exam during onboarding.
Employees must have the ability to demonstrate and maintain gown qualification standards.

Nice To Haves

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.

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.
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.