Aseptic Filling Technician- 2nd Shift

Kindeva Drug Delivery•Maryland Heights, MO

About The Position

Works in a clean room environment, requiring gowning qualification and adherence to good aseptic techniques, to produce aseptically filled injectable drug products. The position requires an understanding of cGMP and involves operating filling machines and aseptically assembling components used on some machines. The employee must pass sterile gown and media fill qualification and may be required to use a respirator.

Requirements

High school diploma, GED, or associate’s degree.
Ability to read and comprehend instructions, correspondence, technical documents, and detailed documentation.
Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.
Ability to calculate percentage accountabilities and reconcile numerical values.
Proficiency operating computerized systems and software.
Ability to apply common-sense understanding to written, oral, or diagram-based instructions.
Ability to write correspondence and effectively present information in one-on-one and small-group situations to other employees.
Must pass sterile gown and media fill qualification.
Must not be claustrophobic.
Must achieve a score of 9 or above for near vision at 14 inches with both eyes using a Titmus II vision tester.
Must be able to perform the physical requirements of the position, including regularly using hands to handle objects, standing and walking, climbing or balancing, and stooping, kneeling, crouching, or crawling; occasionally lifting or moving up to 40 pounds; and bending, squatting, pushing, pulling, and reaching above shoulder level.
Must be able to wear required safety equipment; respirator use may be required.

Responsibilities

Follow aseptic behavioral requirements and cGMP requirements.
Operate component assembly machines and filling machines.
Unload sterilizers and properly handle components and machine parts.
Maintain accountability and complete batch records, logbooks, and other GMP documentation accurately and completely.
Work in a clean room environment.
Clean and disinfect or sanitize stationary equipment and room surfaces in cGMP areas according to procedures to maintain a sterile environment.
Perform department housekeeping duties in accordance with SOPs.
Perform other assigned duties, such as drug filtration, personnel plating, and daily inventory checks of clean room parts.
Participate in process improvement activities.
Demonstrate behaviors aligned with the company’s PRECISE Values.
Wear required safety equipment, work safely, use proper lifting techniques, and remain aware of surrounding hazards.