Aseptic Manufacturing Excellence Operator - 2nd Shift

Kindeva Drug Delivery; Missouri; On-site; USD 55,000 - 75,000; Full time

Job summary

Kindeva Drug Delivery in St. Louis, MO, is seeking a Manufacturing Excellence Operator to support aseptic operations in a clean room environment. You will assist with setup, operation of high-speed equipment, sterilization, and component handling, working on first shift.

This role requires adherence to cGMP and SOPs, strong attention to safety, ability to follow complex instructions, and ability to participate in continuous improvement activities with maintenance staff.

Qualifications

• 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, correspondences, and technical documents.
• Ability to perform basic math and calculations for accountability and density calculations.
• Proficiency in operating computerized systems and software.
• Ability to follow detailed documentation accurately.

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 problems.
• Responsible for sanitizing Clean Room areas per procedures.
• Assure drug and raw materials accountability is maintained.
• Review and perform proper documentation and in-process test results as required.
• Must unload sterilizers, handle components, verify counts, and assign to batches.
• Prepare solutions for other departments.
• Perform housekeeping duties per SOPs.
• Must operate assigned machines and aseptically hand-assemble components.
• Must clear jams and perform tabletop adjustments on equipment.
• Must setup, tear down and changeover Clean Room machinery.
• Complete training requirements and stay current with training timelines.
• Participate in continuous improvement events/activities.
• Assist maintenance with equipment issues and perform asset care.
• Other duties as assigned.

Skills

Reading comprehension

Mathematics calculations

Computerized systems

Documentation accuracy

GMP knowledge

Education

High school diploma or GED with 2 years related experience; Associates/Technical degree preferred

Tools

Equipment operation software

Job description

Kindeva Drug Delivery in St. Louis, MO, is seeking a Manufacturing Excellence Operator to support aseptic operations in a clean room environment. You will assist with setup, operation of high-speed equipment, sterilization, and component handling, working on first shift.

This role requires adherence to cGMP and SOPs, strong attention to safety, ability to follow complex instructions, and ability to participate in continuous improvement activities with maintenance staff.