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 first-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, and 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; report any problems to the department supervisor.
• Sanitize Clean Room areas in accordance with applicable procedures.
• Maintain drug and raw materials (RMP’s and RMC’s) accountability.
• Review and perform proper accountability, documentation, and quality in-process test results as required per SOP or Batch Record (and logbooks).
• Unload sterilizers, handle components, verify counts, and assign to respective batches.
• Prepare solutions for other departments.
• Perform housekeeping duties per SOP’s.
• Operate assigned machines and/or 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, including tabletop adjustments.
• Complete and maintain all training requirements for the position; show proficiency in required job functions.
• Participate in continuous improvement events/activities.
• Assist maintenance technicians with equipment issues; 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 follow instructions, correspondence, and technical documents.
• 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 apply common sense to carry out instructions in written, oral, or diagram form.
• Ability to review detailed documentation for accuracy and completeness.
• 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; must pass respirator training if necessary.
• Must pass gowning training and become gown-qualified to enter the Aseptic area.
• Experience participating in continuous improvement events/activities is a plus.

Physical Qualifications

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

Occupational Exposure/Risk Potential

• Work environment includes exposure to 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 and questionnaires may apply to some products manufactured.