Manufacturing Technician II - Sterile Filling Hardware
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Manufacturing / Production
Pharmaceutical Manufacturing, Manufacturing & Industrial Operations, Production Associate / Production Line
Job Description & How to Apply Below
Location:
West Chester Township, Ohio
Compensation: $22 - 32 USD / hour
AboutThe Role Manufacturing Technician II
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.
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…
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