Manufacturing Technician III, Device Assembly
ResilienceAbout the role
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
Shift: 12hr (6am-630pm) 2-2-3 (2 on, 2 off, every other weekend) schedule
This position will require working in various Controlled/Non-Classified areas. The Manufacturing Technician III performs a variety of manufacturing tasks (operates equipment, performs in-process monitoring, line clearances, cosmetic inspection, cleaning and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) to achieve a prescribed level of purity, quality, and consistency in product and work output in accordance with cGMPs.
Job Responsibilities
• Perform the duties of operating assigned machinery consisting of servicing machines with materials, monitoring equipment status, reintroduction of materials, manually palletizing finished materials, and assuring a smooth flow of product.
• Be able to start-up machinery including equipment set-up, perform recipe selection and data entry on manufacturing computerized system (SCADA and HMI), make minor adjustments, and perform critical sensor challenges.
• Perform manual packaging tasks as required including hand packaging and rework of in-process and finished material.
• Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts)as the need arises to safely move, store or deliver material to the proper location.
• Perform visual quality inspection and sampling of in-process materials. Promptly escalate concerns to Lead and Process Facilitator as needed.
• Perform minor troubleshooting including clearing minor jams and identifying equipment defects. Work collaboratively with technical resources to resolve equipment issues as needed.
• Perform inventory control and reconciliation activities, which may require the use of SAP and WES in a limited role.
• Perform cleaning, housekeeping and line clearance activities for assigned areas to maintain a cGMP environment. This includes assembling, disassembling and sanitizing various packaging equipment.
Perform batch record and GMP documentation entries. Perform mathematical computation as
needed.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety and quality procedures.
• Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
• Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications.
• Review process documents such as operational SOPs, forms, and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Execute protocols as required as a part of equipment qualification and process validation work.
• Be flexible and support other work areas within the Manufacturing Team as needed.
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
Competencies & Job Requirements:
• 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 on-going basis to contribute to the success of the Process Execution Team.
• Ability to work effectively in a team environment.
• Candidate should possess the ability to work in and adapt to a changing/demanding environment.
• Some overtime may be required with minimal advance notice to support business needs.
Minimum Requirements
• Advanced 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 a
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