<p>Description</p> <p>Position Summary:</p> <ul> <li>Perform all work in compliance with company policy and within the guidelines of Biomerieux's Quality System. </li><li>Oversee the production process to ensure quality and efficiency targets are met per the production schedule. Requires judgement on when to escalate issues for resolution including quality issues, equipment issues, and software issues. </li><li>Automation machine operator is responsible for ensuring quality work is being performed, including but not limited to: proper adherence to line clearances, adherence to written procedures (WIDs, BRs, & SOPs), completion of QSR documentation, and proper identification and segregation of conforming and non-conforming product. </li><li>Oversee the high volume and high value of product output. Interfaces with high value equipment. </li><li>Maintain records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures. </li><li>Maintain organization and cleanliness of assigned production area. </li><li></li><li>Perform routine cleaning of assigned equipment. </li><li>Develop a thorough understanding of the assigned equipment in order to identify improvement opportunities. </li><li>Provide training when necessary to new machine operators in assigned area. </li><li>Operate automated production equipment. </li><li>Perform in-process testing to ensure product meets specifications and document results. </li><li>Responsible for monitoring material control requirements of materials associated with automated machine operation including released status, expiration, and scrap transactions. </li><li>Assist Engineering/line maintenance in machine repairs or other tasks as/if needed. </li><li>Load and unload raw materials and subassemblies. </li><li>Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR). </li><li>Must be able to learn and be able to hydrate inner primer plates to be used in our process. </li></ul> <p>Perform other duties as assigned.</p> <p>Training and Education:</p> <ul> <li>External candidates must have a good understanding of contamination prevention and experience operating automated equipment. </li><li>Experience with electronic documentation systems is preferred. </li><li>Requires a high school diploma or equivalent. </li></ul> <p>Experience:</p> <ul> <li>For internal candidates, a minimum of 6 months of manufacturing experience at Biomerieux is required. </li><li>Consideration will be given to applicants with less than 6 months of internal manufacturing experience if prior machine operator experience in a regulated manufacturing environment can be shown. </li><li>For external applicants, a minimum of 2 years as a machine operator in an FDA/ISO regulated manufacturing environment is required. </li></ul> <p>Knowledge, Skills, Abilities:</p> <ul> <li>Must have good reading, writing, and oral communication and comprehension skills. </li><li>Must have a high attention to detail. </li><li>Must have good math skills. </li></ul> <p>Must be able to work in a team environment and have a positive, professional manner.</p> <p>Working Conditions:</p> <p>Ability to ascend/descend stairs, ladders, ramps, and the like.</p>