U-09 Aseptic Production Support Operator

Kindeva Drug Delivery•Brentwood, MO

10d•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. 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. BASIC QUALIFICATIONS High school diploma / general education degree (GED) or an Associate’s degree plus 1 year Manufacturing / Packaging work experience or Veterans/Military TECHNICAL QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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. PHYSICAL QUALIFICATIONS The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls. The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee 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. This is a 3rd shift position. #LI-Onsite #BM1 California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer: Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

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.
Cannot be claustrophobic.
Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.

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.