Manufacturing Technician III, Parts Prep (Day Shift)

RESILIENCE US INC • Hamilton, OH • 4h ago

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 Position Summary The Manufacturing Technician III (Parts Prep) requires working in various Controlled/Non-Classified areas. The Parts Prep Technician operates equipment such as parts washers and autoclaves, inspects, cleans, and sterilizes equipment, assembles/disassembles equipment, performs area cleanings in accordance with the cleaning schedule, and completes batch record entries. Responsibilities

Perform the duties of operating assigned machinery consisting of parts washers and autoclaves, etc.

Responsible for assembling, disassembling, wrapping, operating and rinsing/sanitizing various equipment.

Perform set-up activities, including-but not limited to-cleaning/stocking the area, spraying items through the airlock, and setting up parts wash and autoclave loads per SOP/Form.

Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

Perform visual inspections of equipment for cleanliness as specified per SOP.

Obtain knowledge to be able to print off SOP's/Forms via EDMS.

Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed.

Knowledge of product security controls and material handling equipment.

Become aseptically qualified to enter the aseptic core area to unload autoclaves and component processing.

Responsible for the outgoing quality level.

Obtain a novice to intermediate level of knowledge of SAP inventory movements and inventory management such as moving items from one storage location to another and goods issuing items to process orders as required.

Minimum Qualifications Significant experience in a pharmaceutical or cGMP-regulated environment

Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language. Good attention to detail is required. Individual must be capable of keeping accurate records and performing 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. This position may also include the following conditions:

Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals.

Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.

Assist mechanical staff with preventive maintenance procedures, as required.

The items described here are representative of those that must be met successfully to perform the essential functions of this job. 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, phys

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