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 world.

The Impact You Will Make

In 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 standards.

Role Responsibilities

• Must follow all aseptic/sterile/cGMP techniques.
• Continually meet cleanroom gowning requirements and adhere to aseptic technique principles at all times inside the Processing Area.
• Check clean room/filling processes to ensure compliance with cGMP and departmental procedures and report any problems to the department supervisor.
• Responsible for sanitizing Clean Room areas in accordance with applicable procedures.
• Assure drug and raw materials (RMP's and RMC's) accountability is maintained.
• Review 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 batches.
• Prepare solutions for other departments.
• Perform appropriate housekeeping duties per SOP's.
• Must be able to operate any/all assigned machines and/or equipment and aseptically hand assemble components.
• Must be able to clear jams and perform tabletop adjustments required on equipment.
• Must be able to setup, tear down and changeover all Clean Room isolated machinery, and perform tabletop adjustments required on equipment.
• Must 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 requirements.

• Participate in continuous improvement event/activities.
• Must assist maintenance technicians with equipment issues. Operators will be required to perform operator / asset care of equipment as assigned.
• Other duties as assigned.

Basic Qualifications

• High school diploma or general education degree (GED) with a minimum of 2 years of related experience; Associates or Technical Degree preferred
• Must 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 organization.
• Must 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 calculations.
• Proficiency in operating computerized systems and software.
• Must demonstrate the ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Must follow and review detailed documentation for accuracy and completeness.

Technical Qualifications

• Must be able to clear jams and perform tabletop adjustments required on equipment.
• Must be able to setup, tear down and changeover all Clean Room isolated machinery.
• Have ability to wear a respirator and if necessary, must pass respirator training.
• Must be able to pass gowning training and become gown qualified to enter the Aseptic area.
• Experience participating in continuous improvement events/activities is a plus.

Physical Qualifications

• The employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, or crouch.
• The employee must occasionally lift and/or move up to 60 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust and focus.
• The employee must wear all required safety equipment and perform assigned work in a safe manner.
• Employee must use proper lifting techniques and be conscious of hazards around him/her.
• Must follow all GMP and safety procedures within the department.

Occupational Exposure/Risk Potential

Work 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.