U-09 Manufacturing Excellence Operator III- 2nd Shift

Our Work Matters At Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeIn a Clean Room environment this role will be responsible for supporting all activities associated with aseptic operations including but not limited to: setup disassembly and operation of high-speed equipment; preparing and sterilizing components and equipment; support and participating in improvement and equipment asset care activities associated with aseptic operations while following current SOP and cGMP RESPONSIBILITIESMust follow all aseptic/sterile/cGMP meet cleanroom gowning requirements and adhere to aseptic technique principles at all times inside the Processing clean room/filling processes to ensure compliance with cGMP and departmental procedures and report any problems to the department for sanitizing Clean Room areas in accordance with applicable drug and raw materials (RMPs and RMCs) accountability is and perform as required proper accountability documentation and quality in-process test results as required per the applicable SOP or Batch Record (and logbooks).Must be able to unload sterilizers and properly handle components receive components verify counts and assign to respective solutions for other appropriate housekeeping duties per be able to operate any/all assigned machines and/or equipment and aseptically hand assemble be able to clear jams and perform tabletop adjustments required on be able to setup tear down and changeover all Clean Room isolated machinery and perform tabletop adjustments required on complete and maintain all training requirements for position and show proficiency in required job functions. Employees must complete all training in assigned training target times and stay current with training in continuous improvement event/ assist maintenance technicians with equipment issues. Operators will be required to perform operator / asset care of equipment as duties as QUALIFICATIONSHigh school diploma or general education degree (GED) with a minimum of 2 years of related experience; Associates or Technical Degree preferredMust be able to read and comprehend instructions correspondence and technical documents. Ability to effectively present information in one-on-one and small group situations to other employees of the demonstrate the ability to add subtract multiply and divide in all units of measure using whole numbers common fractions and decimals. Ability to perform calculations for percent accountability reconciliation of numerical values and bulk density in operating computerized systems and demonstrate the ability to apply common sense understanding to carry out instructions furnished in written oral or diagram follow and review detailed documentation for accuracy and QUALIFICATIONSMust be able to clear jams and perform tabletop adjustments required on be able to setup tear down and changeover all Clean Room isolated ability to wear a respirator and if necessary must pass respirator be able to pass gowning training and become gown qualified to enter the Aseptic participating in continuous improvement events/activities is a QUALIFICATIONSThe employee is regularly required to use hands to finger handle or feel objects tools or employee is regularly required to stand and walk; climb or balance; and stoop kneel or employee must occasionally lift and/or move up to 60 vision abilities required by this job include close vision distance vision color vision peripheral vision depth perception and the ability to adjust and employee must wear all required safety equipment and perform assigned work in a safe must use proper lifting techniques and be conscious of hazards around him/ follow all GMP and safety procedures within the EXPOSURE/RISK POTENTIALWork environment includes the ability to work with high potent chemical compounds hazard materials toxics and control substances. Must be willing to adhere to stringent PPE requirements safe work methods and practices for personal and product protection. Attention to detail instructions and following other safe practices are key requirements as well. Medical surveillance protocols and questionnaires may be part of some of the products to be manufactured.#LI-onsite #LI-BM1