Manufacturing Technician II, Packaging

Benefits

Additional Information

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 This position will require working in various Controlled/Non-Classified areas. The Packaging Technician 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. - 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 - 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 Background - High school graduate, vocational school graduate or equivalent - Working knowledge of Microsoft applications and SAP - Prior production experience - Experience working in a LEAN manufacturing environment - Knowledge of cGMPs and FDA policies/procedures Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer