Manufacturing Excellence Operator-2nd Shift

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, and Transdermal/Intradermal Patch Technologies. We partner with customers to improve patient outcomes worldwide.

About the role

In a Clean Room environment, this second-shift role supports all activities associated with aseptic operations, including setup, disassembly, and operation of high-speed equipment; preparing and sterilizing components; and participating in improvement and equipment asset care activities while following current SOP and cGMP standards.

Responsibilities

• Follow all aseptic/sterile/cGMP techniques and cleanroom gowning requirements.
• Monitor clean room/filling processes to ensure compliance with cGMP and departmental procedures; report any problems to the supervisor.
• Sanitize Clean Room areas in accordance with applicable procedures.
• Maintain drug and raw materials accountability.
• Review and perform proper accountability, documentation, and quality in-process test results as required per SOP or Batch Record.
• Unload sterilizers, handle components, verify counts, and assign to respective batches.
• Prepare solutions for other departments.
• Perform housekeeping duties per SOP.
• Operate assigned machines/equipment and aseptically hand-assemble components.
• Clear jams and perform tabletop adjustments on equipment.
• Set up, tear down, and change over all Clean Room isolated machinery.
• Complete and maintain all training requirements for the position and demonstrate proficiency in required job functions.
• Participate in continuous improvement events/activities.
• Assist maintenance technicians with equipment issues and perform operator/asset care of equipment as assigned.
• Other duties as assigned.

Requirements

• High school diploma or GED with a minimum of 2 years of related experience; Associate’s or Technical Degree preferred.
• Ability to read, comprehend, and present information effectively.
• Proficiency in basic arithmetic (addition, subtraction, multiplication, division) and calculations for percent accountability, reconciliation, and bulk density.
• Proficiency in operating computerized systems and software.
• Ability to follow detailed documentation and ensure accuracy and completeness.

Qualifications

• Ability to clear jams and perform tabletop adjustments on equipment.
• Ability to set up, tear down, and change over Clean Room isolated machinery.
• Ability to wear a respirator and pass respirator training if necessary.
• Ability to pass gowning training and become gown qualified to enter the Aseptic area.
• Experience participating in continuous improvement events/activities is a plus.

Physical Requirements

• Regularly required to use hands to handle objects, tools, or controls.
• Regularly required to stand, walk, climb, balance, stoop, kneel, or crouch.
• Occasionally lift and/or move up to 60 pounds.
• Specific vision abilities include close, distance, color, peripheral, depth perception, and the ability to adjust focus.
• Must wear all required safety equipment and perform work safely.
• Must follow proper lifting techniques and be aware of hazards in the work environment.

Occupational Exposure

Work environment includes handling high-potent chemical compounds, hazardous materials, toxics, and controlled substances. Must adhere to stringent PPE requirements, safe work methods, and practices for personal and product protection. Attention to detail and following instructions are critical. Medical surveillance protocols may apply for some products.

This position is for second shift.