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 of area, spraying items through airlock, 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. Must obtain visual inspection training certification.
Obtain knowledge to be able to print off SOP's/Forms via ECMS.
Perform batch record and GMP documentation entries. Maintain records and/or logs as required to perform job responsibilities. This will include mathematical computation where needed.
Knowledge of product security controls and material handling equipment.
Responsible for 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 issuing goods to process orders as required.
Responsibly perform work requirements, 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 the Area Manager.
Assist mechanical staff with preventive maintenance procedures, as required.
Requirements
Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
Good attention to detail is required.
The individual must be capable of keeping accurate records and performing mathematical calculations
High school graduate, vocational school graduate or equivalent
Experience in a pharmaceutical or cGMP-regulated environment. Prior production experience
Experience working in a LEAN manufacturing environment. Knowledge of cGMPs and FDA policies/procedures
Work Schedule:
12 hour - 2/2/3
This position may also include the following conditions:
Support lean activities by participating in 5S and other process improvement activities.
Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
Be flexible in training and supporting other functional areas as needed.
Perform all other assigned duties with minimal supervision under the direction of the Area Manager or designee as needed.
Send out pass down communications as required.
May be required to become media qualified to assist with production activities in other functional areas.
May be required to obtain cold room training/access to be able to transfer materials in and out of the cold rooms.
May be required to take proper training to become a certified trainer within the area.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Sponsorship or support for work authorization, including visas, is not available for this 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.
For more information, please visit www.resilience.com
Position Summary
This position requires working in various Controlled/Non-Classified areas. The Manufacturing Technician II operates equipment such as parts washers and autoclave, inspects, cleans, and sterilizes equipment, assembles/disassembles equipment, performs area cleanings in accordance with cleaning schedule, and completes batch record entries.
Resilience · - OH - West Chester