Aseptic Filling Technician- 2nd Shift

Kindeva; Missouri; On-site; USD 40,000 - 60,000; Full time

Job summary

Kindeva Drug Delivery in Missouri is seeking a dedicated team member to work in a clean room environment. The role involves operating filling machines, aseptically assembling components, and maintaining strict gowning and sterility standards to produce injectable products.

Responsibilities include following GMP procedures, completing batch records, and supporting process improvements while adhering to company PRECISE Values.

Qualifications

• Must read and comprehend instructions and technical documents.
• Ability to perform calculations with percent accountability and decimals.
• Proficient in operating computerized systems and software.

Responsibilities

• Follows aseptic behavioral requirements.
• Follows cGMP requirements.
• Operate component assembly machines and filling machines.
• Unload sterilizers and properly handle components and machine parts.
• Documentation of batch records, logbooks, and other GMP documents.
• Works in a clean room environment.
• Perform cleaning and sanitization of equipment and room surfaces to maintain sterility.
• Carry out department housekeeping per SOPs.
• Perform other duties as assigned (e.g., drug filtration, plating, inventory checks).
• Participate in process improvements activities.
• Demonstrate behaviors aligned to PRECISE Values.

Skills

Reading comprehension

Numerical calculations

Computer literacy

Documentation skills

Gowning qualification

Education

High school diploma or GED or associate's degree

Job description

Role SummaryWorks in a clean room environment which requires gowning qualification and adherence to good

Role SummaryWorks in a clean room environment which requires gowning qualification and adherence to good aseptic techniques to produce aseptically filled injectable drug products. The position requires cGMP understanding and involves operating of the filling machines and aseptically assembling components used on some of the machines.

Role Responsibilities

• Follows aseptic behavioral requirements.
• Follows cGMP requirements
• Operate component assembly machines and filling machines.
• Unload sterilizers, properly handle components and machine parts.
• Perform proper accountability & documentation batch records, logbooks, and other GMP documents)
• Works in a clean room environment.
• Perform cleaning and disinfection / sanitization of stationary equipment, room surfaces in all cGMP room areas to ensure compliance with all sanitization procedures to maintain a sterile environment.
• Perform appropriate department housekeeping duties per SOPs.
• Other duties as assigned (e.g., drug filtration, personnel plating, daily inventory clean room parts checks, etc.)
• Participate in process improvements activities.
• Will demonstrate behaviors aligned to the company’s PRECISE Values.

Basic Qualifications

• High school diploma or general education degree (GED) or associate’s degree.
• Must be able to read and comprehend instructions, correspondence, and technical documents.
• Must demonstrate the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to perform calculations for percent accountabilities and reconciliation of numerical values.
• Proficiency in operating computerized systems and software.
• Must demonstrate the ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Must follow and review detailed documentation for accuracy and completeness.

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 accommodation may be made to enable individuals with disabilities to Perform The Essential Functions.

• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
• 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.
• Must be able to pass Sterile gown and media fill qualification.
• Position may require use of a respirator.

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.

• 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.
• Must achieve a score of 9 or above for near vision (14”) with both eyes using a Titmus II vision tester.
• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
• The employee must wear all required safety equipment and perform assigned work in a safe manner.
• Employee must use proper lifting techniques and be conscious of hazards around him/her.

California residents should review our Notice for California Employees and Applicants before applying.

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?