Manufacturing Technician II - Sterile Filling

Resilience•West Chester, OH

1d•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 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. The Filling Technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning, and batch record entries in accordance with cGMPs.

Requirements

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.
As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards.

Nice To Haves

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.

Responsibilities

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.