Manufacturing Excellence Operator- 2nd Shift

Kindeva; Bridgeton, Northern (MO, KY); Hybrid; USD 36,000 - 48,000; Full time

Job summary

Kindeva is seeking a Manufacturing Excellence Operator for the St. Louis, MO area to support aseptic operations in a clean room environment.

This role focuses on setup, disassembly, and operation of high-speed equipment, preparation and sterilization of components, and adherence to SOP and cGMP standards on second shift. The position requires strong aseptic techniques, GMP knowledge, and the ability to follow detailed documentation and training.

Qualifications

• Must have strong aseptic/sterile techniques and GMP familiarity.
• Able to operate high-speed equipment in a clean room.
• Proficiency with basic computerized systems and documentation.

Responsibilities

• Follow aseptic/sterile/cGMP techniques.
• Maintain cleanroom gowning and aseptic practices.
• Verify compliance of fill processes with cGMP and SOPs; report issues.
• Sanitize Clean Room areas per procedures and ensure material accountability.
• Handle components, verify counts, and assign to batches.
• Prepare solutions and perform routine housekeeping.
• Operate assigned machines and perform equipment changes as needed.
• Complete training requirements and participate in continuous improvement.

Skills

Aseptic technique

Equipment operation

GMP knowledge

Education

High school diploma or GED

Associates or Technical Degree preferred

Job description

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 a motivated, talented, and passionate Manufacturing Excellence Operator to join our St. Louis Missouri team!

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.

This position is for Second shift.

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.