Manufacturing Technician II

2 weeks ago

Toledo, Toledo, United States Resilience Corp. Full time
Job Summary

A career at Resilience is more than just a job - it's an opportunity to change the future. Our company 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.

Responsibilities
  • Perform a variety of manufacturing tasks, including operating equipment, performing in-process monitoring, line clearances, cosmetic inspection, cleaning, and completing batch record entries.
  • Support improvement activities, such as 5S, participating in problem-solving and Kaizen events, manual data collection, and process validation work.
  • Operate assigned machinery, including servicing machines with materials, monitoring equipment status, reintroducing materials, manually palletizing finished materials, and ensuring a smooth flow of product.
  • Perform manual packaging tasks, including hand packaging and rework of in-process and finished material.
  • Operate light material handling equipment, such as motorized and manual pallet jacks, non-motorized lifts, to safely move, store, or deliver material to the proper location.
  • Perform visual quality inspection and sampling of in-process materials, and promptly escalate concerns to the Lead and Process Facilitator as needed.
  • Perform minor troubleshooting, including clearing minor jams and identifying equipment defects, and 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, including assembling, disassembling, and sanitizing various packaging equipment.
  • Perform batch record and GMP documentation entries, and perform mathematical computations as needed.
  • Be familiar with job-related safety procedures and hazards, including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls, and report all discrepancies to the 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.
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.

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