Senior Bioprocess Engineer

2 weeks ago

Fort Dodge, Iowa, United States Elanco Animal Health Incorporated Full time
At Elanco (NYSE: ELAN) - it all starts with animals

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy PurposeTM - to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better - join our team today

The Bioprocess Engineer will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network, to guarantee that the production and analytical processes are carried out with appropriate Sterility Assurance standards, in alignment with Global procedures, GMP (Good Manufacturing Practices) and Regulatory expectations, as well as industry best practices.

Acting as a subject matter expert for Sterility Assurance and microbiology, this individual operates cross-functionally and in partnership with process teams in production and TS/MS (Technical Services/Manufacturing Science) to improve the site Sterility Assurance related processes and programs (aseptic training/qualification, APS (Aseptic Process Simulation) program, EM (Environmental Monitoring) program, etc.).

Your Responsibilities:
  • Provide technical and SME input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation and developing and owning the CCS.
  • Author and develop Elanco EFP (Elanco Functional Procedures) supporting Contamination Control, sterile and aseptic process/ cleaning, and disinfection validation plans for the site.
  • Work closely with area owners and suppliers to finalize validation/qualification requirements for facility, process, equipment, and systems, ensuring that company policies, procedures, applicable regulations, best practices, and guidelines are adhered to.
  • Assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.
  • Provide oversite during execution of (re)validation/qualification of product manufacturing, aseptic processing (media fill), media holds, and sterilization (steam) cycles.
  • Support corrective actions including investigating and ensure proper RCI (root cause Investigation/Analysis) and CAPA definition/effectiveness in resolving deviations as relevant to sterility assurance.
What You Need to Succeed (Minimum Qualifications):
  • engineering, microbiology/biology, or equivalent discipline.
  • 3+ years' experience with parenteral, biological, or vaccine sterile filling operations, environmental monitoring, aseptic processing, and sterile gowning.
  • Proven experience with sterile manufacturing risk assessments and remediations implementation.
  • Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency)
What Will Give You a Competitive Edge (Preferred Qualifications):
  • Experience with upstream production of viruses in either cell monolayers, bioreactors and fermenters.
  • Proven record of successfully troubleshooting vaccine processes.
  • Lean manufacturing and six sigma experience.
Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose Some highlights include:
  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to generous PTO)
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Up to 6% 401K matching
Elanco 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

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