Manufacturing Excellence Operator - 2nd Shift

Kindeva Drug Delivery; Missouri; On-site; USD 55,000 - 75,000; Full time

Job summary

Kindeva Drug Delivery in St. Louis, MO, is seeking a Manufacturing Excellence Operator to support aseptic operations in a clean room environment. You will assist with setup, operation of high-speed equipment, sterilization, and component handling, working on first shift.

This role requires adherence to cGMP and SOPs, strong attention to safety, ability to follow complex instructions, and ability to participate in continuous improvement activities with maintenance staff.

Qualifications

• High school diploma or GED with a minimum of 2 years of related experience; Associates or Technical Degree preferred.
• Must be able to read and comprehend instructions, correspondences, and technical documents.
• Ability to perform basic math and calculations for accountability and density calculations.
• Proficiency in operating computerized systems and software.
• Ability to follow detailed documentation accurately.

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 problems.
• Responsible for sanitizing Clean Room areas per procedures.
• Assure drug and raw materials accountability is maintained.
• Review and perform proper documentation and in-process test results as required.
• Must unload sterilizers, handle components, verify counts, and assign to batches.
• Prepare solutions for other departments.
• Perform housekeeping duties per SOPs.
• Must operate assigned machines and aseptically hand-assemble components.
• Must clear jams and perform tabletop adjustments on equipment.
• Must setup, tear down and changeover Clean Room machinery.
• Complete training requirements and stay current with training timelines.
• Participate in continuous improvement events/activities.
• Assist maintenance with equipment issues and perform asset care.
• Other duties as assigned.

Skills

Reading comprehension

Mathematics calculations

Computerized systems

Documentation accuracy

GMP knowledge

Education

High school diploma or GED with 2 years related experience; Associates/Technical degree preferred

Tools

Equipment operation software

Job description

Role Summary

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 First 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.

Technical Qualifications

• 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.
• Have ability to wear a respirator and if necessary, must pass respirator training.
• Must be able to pass gowning training and become gown qualified to enter the Aseptic area.
• Experience participating in continuous improvement events/activities is a plus.

Physical Qualifications

• 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, or crouch.
• The employee must occasionally lift and/or move up to 60 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.
• 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.
• Must follow all GMP and safety procedures within the department.

OCCUPATIONAL EXPOSURE/RISK POTENTIAL

Work environment includes the ability to work with high potent chemical compounds, hazard materials, toxics, and control substances. Must be willing to adhere to stringent PPE requirements, safe work methods and practices for personal and product protection. Attention to detail instructions and following other safe practices are key requirements as well. Medical surveillance protocols and questionnaires may be part of some of the products to be manufactured. 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.