Aseptic Filling Technician

Kindeva Drug Delivery • Maryland Heights, MO

6d

About The Position

The Aseptic Filling Technician works in a cleanroom using sterile and current Good Manufacturing Practice (cGMP) techniques to assemble components and operate filling machines. The position performs aseptic operations, handles sterilized components, and completes required documentation and in-process quality tests according to applicable standard operating procedures (SOPs) and batch records. The technician must maintain aseptic gowning and technique requirements in the Aseptic Processing Area and follow department housekeeping, GMP, and safety procedures.

Requirements

• High school diploma, GED, or associate degree.
• One to three months of related experience and/or training.
• Ability to perform each essential duty satisfactorily; reasonable accommodations may be made for individuals with disabilities.
• Ability to read and comprehend simple instructions, correspondence, and memos.
• Ability to write correspondence.
• Ability to present information effectively in one-on-one and small-group situations to other employees.
• Ability to perform arithmetic using whole numbers, common fractions, and decimals.
• Ability to apply common-sense understanding to carry out written, oral, or diagrammed instructions.
• Must pass and maintain gown certification requirements.
• New external applicants must pass an assessment test.
• Must not be claustrophobic.
• Must achieve a near-vision score of 9 or above at 14 inches with both eyes using a Titmus II vision tester.
• Must wear required safety equipment, work safely, use proper lifting techniques, remain conscious of hazards, and follow department GMP and safety procedures.

Responsibilities

• Follow aseptic and cGMP techniques.
• Operate component assembly machines and filling machines.
• Unload sterilizers and properly handle components.
• Review and perform required accountability, documentation, and quality in-process test results according to applicable SOPs or batch records, including batch records and logbooks.
• Receive components, verify counts, and assign components to respective batches.
• Perform aseptic operations.
• Perform department housekeeping duties according to SOPs.
• Continually meet aseptic gowning requirements and adhere to aseptic technique principles inside the Aseptic Processing Area.
• Participate in process improvement activities.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED