Manufacturing Excellence Operator- 2nd Shift

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

Job summary

Kindeva Drug Delivery in Missouri is seeking an operator to support aseptic manufacturing in a clean room environment. The role involves setup, operation, disassembly of high-speed equipment, preparing components and ensuring sterility in line with cGMP standards.

Key responsibilities include following aseptic techniques, maintaining gowning and documentation, and supporting maintenance and continuous improvement activities.

Qualifications

• High school diploma or GED with 2 years related experience; Associates or Technical Degree preferred.
• Ability to read and comprehend instructions and communicate effectively in one-on-one and small group situations.
• Ability to perform basic arithmetic and calculations for accountability and documentation.
• Proficiency in operating computerized systems and software.
• Ability to follow written, oral or diagrammed instructions with accuracy.
• Must follow and review detailed documentation for accuracy and completeness.

Responsibilities

• Follow aseptic/sterile/cGMP techniques.
• Maintain cleanroom gowning and aseptic technique in processing area.
• Ensure clean room/filling processes comply with cGMP and procedures.
• Sanitize Clean Room areas per procedures.
• Maintain accountability of drugs and raw materials.
• Log and review in-process test results per SOP/Batch Record.
• Unload sterilizers and verify counts; assign to batches.
• Prepare solutions for other departments.
• Perform housekeeping duties per SOPs.
• Operate assigned machines and aseptically hand assemble components.
• Clear jams and perform tabletop adjustments on equipment.
• Set up and changeover all Clean Room machinery.
• Complete required training and stay current with training targets.
• Participate in continuous improvement activities.
• Assist maintenance technicians with equipment issues.
• Other duties as assigned.

Skills

Aseptic techniques

Cleanroom procedures

Documentation & record keeping

Equipment operation

Education

High school diploma or GED

Associates or technical degree

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

In a Clean Room environment, this role will be responsible for supporting all activities associated with aseptic operations, including but not limited to: setup, disassembly and operation of high-speed equipment; preparing and sterilizing components and equipment; support and participating in improvement and equipment asset care activities associated with aseptic operations while following current SOP and cGMP standards.

Role Responsibilities

• Must follow all aseptic/sterile/cGMP techniques.
• Continually meet cleanroom gowning requirements and adhere to aseptic technique principles at all times inside the Processing Area.
• Check clean room/filling processes to ensure compliance with cGMP and departmental procedures and report any problems to the department supervisor.
• Responsible for sanitizing Clean Room areas in accordance with applicable procedures.
• Assure drug and raw materials (RMP's and RMC's) accountability is maintained.
• Review and perform as required, proper accountability, documentation and quality in-process test results as required per the applicable SOP or Batch Record (and logbooks).
• Must be able to unload sterilizers and properly handle components, receive components, verify counts, and assign to respective batches.
• Prepare solutions for other departments.
• Perform appropriate housekeeping duties per SOP's.
• Must be able to operate any/all assigned machines and/or equipment and aseptically hand assemble components.
• Must be able to clear jams and perform tabletop adjustments required on equipment.
• Must be able to setup, tear down and changeover all Clean Room isolated machinery, and perform tabletop adjustments required on equipment.
• Must complete and maintain all training requirements for position and show proficiency in required job functions. Employees must complete all training in assigned training target times and stay current with training requirements.
• Participate in continuous improvement event/activities.
• Must assist maintenance technicians with equipment issues. Operators will be required to perform operator/asset care of equipment as assigned.
• Other duties as assigned.

Basic Qualifications

• High school diploma or general education degree (GED) with a minimum of 2 years of related experience; Associates or Technical Degree preferred
• Must be able to read and comprehend instructions, correspondence, and technical documents. Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
• 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 accountability, reconciliation of numerical values and bulk density calculations.
• 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.
• Must demonstrate …

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.