Senior Associate, Sterility Assurance

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

The Sterility Assurance Consultant 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.).

Job Responsibilities:

• Provide technical and SME input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation and developing and owning the CCS.

• Maintain lifecycle documentation (e.g., validation plans)

• 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.

• Develop and perform OJT’s (on-the-job training) and classroom training of operators and technicians (Ops/Mtn/QC) for SA best practices as required.

• Enhance and expand training program to the next level of maturity as a comprehensive and integrated learning management program.

• Support audit preparation and defend areas of sterility assurance responsibility as a SME.

• Review site change controls to ensure the qualified/validated state of a process is not impacted by a proposed change.

• Ensure SA requirements/best practice are considered at all steps (from URS to qualification/validation) during CapEx (Capital Expenditure) projects.

• Lead the implementation of CI (continuous improvement) projects and other RFT (right first time) initiatives to reduce process risk, optimize plant and process productivity.

• Provide technical leadership to the site and network organization regarding process improvements, updates to industry standards/GMPs and troubleshooting.

• Participate in manufacturing site investigations as needed, enhancing vaccine knowledge, understanding and problem solving.

• Participate in Auto-Inspection/Gemba's to challenge SA aspects.

• Coach and grow technical talent across the functions within the site.

  • Be an active member of integrated team where interaction with several groups is required to coordinate, plan, and implement work including new facilities, critical changes, major deviations, and continuous improvements.

  • Develop SA knowledge and capabilities, in the technical and regulatory fields, including benchmarking best practices across the industry – Network with peers to share learnings.

Basic Minimum Requirements:

• B.S.in microbiology/biology or equivalent experience in lieu of degree

• 3+ years experience with sterile manufacturing

• Experience with a variety of technologies and platforms is preferred including poultry vaccine technologies, recombinant protein platforms, protein-based therapeutics, cell culture and fermentation technology.

• Proven experience with sterile manufacturing and risk assessments and remediations implementation.

• Familiarity with Global Regulatory Standards FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), CFIA (Canadian Food Inspection Agency), as applicable.

• Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills and Preferences:

• Experience with upstream production of viruses in either cell monolayers, bioreactors and fermenters

• Proven record of successfully troubleshooting vaccine processes

• Experience with biologicals manufacturing and aseptic manufacturing

• Lean manufacturing and six sigma experience

• Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential.

• Personal attributes: self-starter; attentive to details; results oriented; accountable; respectful of others; committed while maintaining balance and perspective; good written and oral communication skills.

• Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

• Ability to problem solve using innovative thinking and good decision making.

• Ability to influence people

• Ability to build collaborative relationships with areas inside and outside of Elanco

Travel

• 0-10% Domestic and International travel

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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