Operator- Inoculum/ Cell Culture Processing - United States
- We unite caring with discovery to make life better for people around the world.
- We are a global healthcare leader headquartered in Indianapolis, Indiana.
- Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
- We give our best effort to our work, and we put people first.
- We’re looking for people who are determined to make life better for people around the world.
- Perform actual duties in an assigned area within the biopharmaceutical bulk products production facility according to cGMP standards.
- Duties are listed below and are specific to the assigned area (Cell Culture/Inoculum).
- The Cell Culture processing areas are PLC automated and controlled via HMI.
- Cell Culture operations contains major equipment such as stainless steel bioreactors and vessels, centrifuges, bio-safety cabinets, and the use of filtration technologies.
- The Inoculum Lab consists of incubators, refrigerators/freezers, cell counters (manual and automated) and sterile operations in bio-safety cabinets.
- Prepare and operate equipment according to written procedures.
- Examples include: setup and sterilization of components and process equipment, monitoring equipment parameters and making adjustments to operational settings, in-process sampling, and performing routine assays.Record data, log activities, and monitor processes according to cGMP standards.
- Perform general maintenance and assists in troubleshooting of equipment.Review batch records for completeness and accuracy.
- Author and/or revise standard operating procedures and batch records.
- May participate in non-conformance event investigations and/or change controls.
- Train junior/new operators.Maintain an elevated level of safety awareness. Communicate safety issues to management in a timely manner.
- Adhere to all safety, environmental, quality, and EEO/AA standards and policies of the Corporation.Perform all duties with a high level of honesty and integrity.
- Bachelor's Degree in biology, chemistry, or related disciplineMinimum of 3 years of manufacturing experience (process operations, technician cell culture, formulations)Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- Qualified candidates must be legally authorized to be employed in the United States.
- Our company does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Ability to understand technical nomenclature and language as well as work with mathematical formulas.
- Must have good manual dexterity and demonstrated mechanical aptitude.
- Must be able to follow detailed instructions and record information clearly and accurately.
- Must possess excellent communication, interpersonal, and written skills.
- Demonstrated knowledge and experience in aseptic processing techniques
- Must be able to apply technical and operational experience to aid in problem solving activities.
- Our company is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
- Must meet the physical requirements of the job; must have the ability to:Lift a minimum of 50 lbs.Bend, reach, stretch, climb ladders, and work in tight spaces.Stand for long periods.Wear appropriate clean room attire.