Aseptic Filling Technician- 2nd Shift

Kindeva•Maryland Heights, MO

About The Position

The Aseptic Filling Technician works in a clean room environment to produce aseptically filled injectable drug products. The role requires gowning qualification, adherence to good aseptic techniques, and an understanding of cGMP requirements. The technician operates filling and component assembly machines and may aseptically assemble components used on some machines. The position also involves handling sterilized components and machine parts, maintaining accurate GMP documentation, and cleaning and sanitizing equipment and room surfaces to maintain a sterile environment. The technician performs department housekeeping and other assigned duties, which may include drug filtration, personnel plating, and daily clean-room parts inventory checks. The role participates in process improvement activities and requires behavior aligned with the company’s PRECISE Values. 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, and technical documents.
Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.
Ability to calculate percentage accountabilities and reconcile numerical values.
Proficiency in operating computerized systems and software.
Ability to use common-sense understanding to carry out written, oral, or diagram-form instructions.
Ability to follow and review detailed documentation for accuracy and completeness.
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.
Must pass sterile gown and media fill qualification.
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 use proper lifting techniques and remain conscious of hazards.

Responsibilities

Follow aseptic behavioral requirements.
Follow cGMP requirements.
Operate component assembly machines and filling machines.
Unload sterilizers and properly handle components and machine parts.
Maintain accurate accountability and documentation, including batch records, logbooks, and other GMP documents.
Work in a clean room environment.
Clean and disinfect or sanitize stationary equipment and room surfaces in cGMP areas according to procedures.
Perform department housekeeping duties according to SOPs.
Perform other assigned duties, which may include 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 and perform assigned work safely.