U-Manufacturing Excellence Operator III

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well‑being for patients around the world.

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; supporting and participating in improvement and equipment asset care activities associated with aseptic operations while following current SOP and cGMP standards.

• 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 (RMPs and RMCs) accountability is maintained.
• Review and perform proper accountability, documentation and quality in‑process test results as required per SOP or Batch Record and logbooks.
• 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 SOPs.
• Operate any/all assigned machines and/or equipment and aseptically hand assemble components.
• Clear jams and perform tabletop adjustments required on equipment.
• Setup, tear down and changeover all Clean Room isolated machinery and perform tabletop adjustments required on equipment.
• Complete and maintain all training requirements for the 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 events/activities.
• Assist maintenance technicians with equipment issues. Operators will be required to perform operator/asset care of equipment as assigned.
• Other duties as assigned.

• High school diploma or 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, and present information in one‑on‑one and small group situations.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Perform calculations for percent accountability, reconciliation of numerical values and bulk density calculations.
• Proficiency in operating computerized systems and software.
• Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Follow and review detailed documentation for accuracy and completeness.

• Clear jams and perform tabletop adjustments required on equipment.
• Setup, tear down and changeover all Clean Room isolated machinery.
• Ability to wear a respirator and pass respirator training if necessary.
• Pass gowning training and become gown qualified to enter the Aseptic area.
• Experience participating in continuous improvement events/activities is a plus.

• Regularly use hands to finger, handle, or feel objects, tools, or controls.
• Regularly stand, walk, climb or balance; and stoop, kneel, or crouch.
• Occasionally lift and/or move up to 60 pounds.
• Specific vision abilities required: close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
• Wear all required safety equipment and perform assigned work in a safe manner.
• Use proper lifting techniques and be conscious of hazards around the employee.
• Follow all GMP and safety procedures within the department.

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.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

California residents should review our Notice for California Employees and Applicants before applying.