Aseptic Manufacturing Excellence Operator 2nd Shift

Kindeva Drug Delivery; Bridgeton (MO); On-site; USD 42,000 - 54,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Manufacturing Excellence Operator for the 2nd shift in Bridgeton, MO. In a clean room environment, you will support aseptic operations, including setup, disassembly, sterilization prep, and equipment asset care in accordance with SOPs and cGMPs.

You will follow strict aseptic techniques, participate in continuous improvement activities, and collaborate with maintenance and production teams to ensure accurate documentation, material accountability, and safe

Qualifications

• Must have a high school diploma or GED with at least 2 years of related experience; Associates or technical degree preferred.
• Ability to read and comprehend instructions, communicate effectively in one-on-one and small groups.
• Must perform arithmetic including percent accountability, reconciliation, and bulk density calculations.
• Proficiency operating computerized systems and software.
• Ability to apply common sense in following written, oral, or diagrammatic instructions.
• Must follow and review detailed documentation for accuracy and completeness.

Responsibilities

• Follow all aseptic/sterile/cGMP techniques.
• Meet cleanroom gowning requirements and adhere to aseptic principles.
• Ensure compliance of clean room/filling processes with cGMP; report issues.
• Sanitize Clean Room areas per procedures.
• Maintain accountability for drugs and raw materials.
• Review and document in-process test results per SOP/Batch Record.
• Unload sterilizers, receive, count, and assign components to batches.
• Prepare solutions for other departments.
• Operate assigned machines and aseptically hand-assemble components.
• Clear jams and perform tabletop adjustments on equipment.
• Setup, teardown and changeover Clean Room isolated machinery.
• Complete training requirements and stay current with training targets.
• Participate in continuous improvement events/activities.
• Assist maintenance technicians with equipment issues.

Skills

Read and comprehend instructions

Computerized systems

Mathematical calculations

Attention to detail

Education

High school diploma or GED; Associates/Technical Degree preferred

Tools

None

Job description

Kindeva Drug Delivery is seeking a Manufacturing Excellence Operator for the 2nd shift in Bridgeton, MO. In a clean room environment, you will support aseptic operations, including setup, disassembly, sterilization prep, and equipment asset care in accordance with SOPs and cGMPs.

You will follow strict aseptic techniques, participate in continuous improvement activities, and collaborate with maintenance and production teams to ensure accurate documentation, material accountability, and safe