Resilience
Manufacturing Technician III, Sterile Filling (Night Shift)
Resilience, West Chester, Ohio, United States
Manufacturing Technician III, Sterile Filling (Night Shift)
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.
Job Summary The Manufacturing Technician III reports to the Supervisor/Manager of Manufacturing on the manufacturing floor, supporting sterile operations. This position requires working in various controlled/non‑classified and classified areas, operating equipment, performing in‑process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning, and completing batch record entries in accordance with cGMPs. The role works a night shift (6:00‑6:30 am) on a 2‑2‑3 rotational schedule.
Job Responsibilities
Operate assigned machinery, servicing filling machines, removing finished materials from machine tables, and ensuring smooth product flow.
Assemble, disassemble, operate, and sanitize various filling equipment.
Perform filter integrity testing per SOP.
Maintain a cGMP environment through cleaning and housekeeping activities.
Start up and make minor adjustments to machinery.
Input data into SCADA/HMI systems.
Conduct visual and physical checks of in‑process and finished materials.
Work with printing devices and printing mats.
Enter batch records and GMP documentation.
Maintain records/logs, including mathematical computations where needed.
Understand product security controls and material handling equipment.
Monitor outgoing quality level.
Understand aseptic behaviors, media fills, and monitor viable/non‑viable equipment.
Control inventory and reconcile activities, using SAP as needed.
Perform all duties in accordance with SOPs, cGMPs, and OSHA safety procedures.
Familiarize with Material Safety Data Sheets for area chemicals.
Apply job‑related safety procedures, including PPE, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to the process facilitator.
Assist mechanical staff with preventive maintenance procedures.
Support lean activities and process improvement, performing 5S, SMED, and manual tracking of OEE and process improvement data.
Assist with executing validation/engineering protocols for processes/equipment.
Propose process improvement suggestions while maintaining quality and cGMP compliance.
Be flexible in training and supporting other filling functions as needed.
Perform all other assigned duties with minimal supervision.
Acquire and maintain all required certifications and qualifications for the assigned work area.
Capable and motivated to learn new skills and develop new capabilities on an ongoing basis to contribute to the success of the Process Execution Team.
Work effectively in a team environment.
Adapt to a changing/demanding environment.
Some overtime may be required with minimal advance notice to support business needs.
Minimum Qualifications
Significant experience in a pharmaceutical and/or cGMP regulated environment.
Strong written and verbal communication in English.
Attention to detail with accurate record keeping and mathematical calculations.
Preferred Qualifications
High school graduate, vocational school graduate, or equivalent.
Prior production experience.
Prior aseptic manufacturing experience.
Experience working in a lean manufacturing environment.
Knowledge of cGMPs and FDA policies/procedures.
Benefits and Compensation The target base pay range for this position is $24.00 – $36.50 per hour. Resilience offers a robust total rewards program, including an annual cash bonus program, a 401(k) plan with generous company match, and a benefits package thoughtfully designed to support employees with great healthcare (medical, dental, vision), family building benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement, and support for caregiving needs.
Equal Employment Opportunity Statement Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non‑job‑related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Requirement – Gown Qualification Standard As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.
#J-18808-Ljbffr
Job Summary The Manufacturing Technician III reports to the Supervisor/Manager of Manufacturing on the manufacturing floor, supporting sterile operations. This position requires working in various controlled/non‑classified and classified areas, operating equipment, performing in‑process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning, and completing batch record entries in accordance with cGMPs. The role works a night shift (6:00‑6:30 am) on a 2‑2‑3 rotational schedule.
Job Responsibilities
Operate assigned machinery, servicing filling machines, removing finished materials from machine tables, and ensuring smooth product flow.
Assemble, disassemble, operate, and sanitize various filling equipment.
Perform filter integrity testing per SOP.
Maintain a cGMP environment through cleaning and housekeeping activities.
Start up and make minor adjustments to machinery.
Input data into SCADA/HMI systems.
Conduct visual and physical checks of in‑process and finished materials.
Work with printing devices and printing mats.
Enter batch records and GMP documentation.
Maintain records/logs, including mathematical computations where needed.
Understand product security controls and material handling equipment.
Monitor outgoing quality level.
Understand aseptic behaviors, media fills, and monitor viable/non‑viable equipment.
Control inventory and reconcile activities, using SAP as needed.
Perform all duties in accordance with SOPs, cGMPs, and OSHA safety procedures.
Familiarize with Material Safety Data Sheets for area chemicals.
Apply job‑related safety procedures, including PPE, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to the process facilitator.
Assist mechanical staff with preventive maintenance procedures.
Support lean activities and process improvement, performing 5S, SMED, and manual tracking of OEE and process improvement data.
Assist with executing validation/engineering protocols for processes/equipment.
Propose process improvement suggestions while maintaining quality and cGMP compliance.
Be flexible in training and supporting other filling functions as needed.
Perform all other assigned duties with minimal supervision.
Acquire and maintain all required certifications and qualifications for the assigned work area.
Capable and motivated to learn new skills and develop new capabilities on an ongoing basis to contribute to the success of the Process Execution Team.
Work effectively in a team environment.
Adapt to a changing/demanding environment.
Some overtime may be required with minimal advance notice to support business needs.
Minimum Qualifications
Significant experience in a pharmaceutical and/or cGMP regulated environment.
Strong written and verbal communication in English.
Attention to detail with accurate record keeping and mathematical calculations.
Preferred Qualifications
High school graduate, vocational school graduate, or equivalent.
Prior production experience.
Prior aseptic manufacturing experience.
Experience working in a lean manufacturing environment.
Knowledge of cGMPs and FDA policies/procedures.
Benefits and Compensation The target base pay range for this position is $24.00 – $36.50 per hour. Resilience offers a robust total rewards program, including an annual cash bonus program, a 401(k) plan with generous company match, and a benefits package thoughtfully designed to support employees with great healthcare (medical, dental, vision), family building benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement, and support for caregiving needs.
Equal Employment Opportunity Statement Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non‑job‑related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Requirement – Gown Qualification Standard As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.
#J-18808-Ljbffr