Shire Jobs

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 Brief Job Description: This position will require working in various Controlled/Non-Classified areas. The Parts Prep Technician 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. Job 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 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 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 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. * 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. Ability to use material handling equipment such as walk behind or Walkie Stacker. Must obtain lift truck certification. Other Responsibilities * 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 process facilitator or designee as needed. * Send out pass down communications as required. Optional Training / Responsibilities * Become media qualified to assist with production activities in other functional areas. * Obtain cold room training/access to be able to transfer materials in and out of the cold rooms. Take proper training to become certified trainer within the area. Minimum Qualifications: * Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language. * Good attention to detail is required. Indiv