U-09 Aseptic Support Operator

Kindeva•Brentwood, MO

3d•Onsite

About The Position

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. Ready to work with purpose? Look no further, we are hiring for passionate Clean & Prep Techs to join our STL- Brentwood team. ROLE RESPONSIBILITIES Must be able to understand, follow, and operate applicable SOP’s and batch records for but not limited to, this equipment; i.e. Autoclaves, Gruenberg Oven, Crest Ultrasonic Cleaner, Huber washer, Capsolut, Drum Roller, and Bausch & Stroebel Washer, Properly document all required entries on of batch records, logbooks and sterilization records including proper performance and documentation of in-process checks. Properly perform and document verification of other technicians on batch records and sterilization records. Properly clean equipment as well as perform and document line clearances. Receive components, verify counts, and assign to batches. Be knowledgeable cGMP’s as related to the above tasks. Perform special projects as directed by the Supervisor. Must be able to consistently follow all required environmental control procedures (example: glove changes, donning of designated coveralls and head covers, handling of components under laminar flow hoods, etc… Must be able to perform cleaning of department including overhead work. Other duties as assigned Participate in process improvement activities.

Requirements

High school diploma / general education degree (GED) or an Associate’s degree plus 1 year Manufacturing / Packaging work experience or Veterans/Military
Ability to read and comprehend simple instructions, correspondence, and memos.
Ability to write correspondence.
Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form.
All new external applicants will be required to pass an assessment test.
Regularly required to use hands to finger, handle, or feel objects, tools, or controls.
Regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl.
Must occasionally lift and/or move up to 40 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust and focus.
Cannot be claustrophobic.
Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.

Responsibilities

Understand, follow, and operate applicable SOP’s and batch records for equipment such as Autoclaves, Gruenberg Oven, Crest Ultrasonic Cleaner, Huber washer, Capsolut, Drum Roller, and Bausch & Stroebel Washer
Properly document all required entries on of batch records, logbooks and sterilization records including proper performance and documentation of in-process checks.
Properly perform and document verification of other technicians on batch records and sterilization records.
Properly clean equipment as well as perform and document line clearances.
Receive components, verify counts, and assign to batches.
Be knowledgeable cGMP’s as related to the above tasks.
Perform special projects as directed by the Supervisor.
Consistently follow all required environmental control procedures (example: glove changes, donning of designated coveralls and head covers, handling of components under laminar flow hoods, etc…
Perform cleaning of department including overhead work.
Participate in process improvement activities.
Other duties as assigned