Overview

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The Process Engineer is responsible for the technical support for the production and development of vaccine products with respect to the process, the equipment, troubleshooting/reliability, delivering capital improvements, data analysis, variability reduction, and regulatory compliance. The Process Engineer will work with both internal functional groups as well as external contractors and vendors. The individual must maintain excellent communication skills as well as ensuring safety and quality in all aspects of work.

Functions:

Process/Reliability Engineering

  • The primary focus for this position will be to provide technical support, serving as the Engineering member of the local Process Team(s), providing engineering solutions to process and equipment related issues within various operational areas
  • Shared responsibility for regulatory compliance, including internal quality standards:
    • Ensure that equipment remains in a state of qualification and calibration
    • Demonstrates an understanding of the hazards of manufacturing processes and supports safety and environmental policies and procedures
    • Ensure changes to processes/equipment are documented appropriately using the change management system
    • Ensure that significant variations in processes are captured in the event/deviation management system, with proper root cause analysis performed and appropriate corrective and/or preventative actions implemented to prevent recurrence
  • Technical expert on the equipment and computer control systems, providing assistance in troubleshooting the process, analyzing data, and conversing with the operations personnel
  • Providing continuous improvement in the process, which will involve working with maintenance and managing capital projects
  • Participate in internal or external training programs to maintain knowledge of modern technology, equipment, and validation principles, such as Six Sigma analyses and Lean Manufacturing techniques
  • Work with Maintenance and Supply Chain personnel on asset lifecycle management, including preventive maintenance programs, calibration, and spare parts identification

Capital Projects Engineering

  • Provide technical support and leadership on capital projects, including selection of appropriate improvements, defining scope, overseeing design/construction, maintaining budgets, and qualifying the equipment
  • Provide training on new equipment and processes as necessary
  • Serve as liaison with Federal, State, and local agencies to ensure compliance with laws and regulations, including site Regulatory & QA personnel to maintain site drawings on file with USDA
  • Participate in site strategic planning and resource assessments to support capital investment/recapitalization and long term goals of the site

Other

  • Work with HSE to ensure contractor safety for any third party work performed
  • Maintain or develop Standard Operating Procedures as needed
  • Some travel will be required
  • Other duties as assigned

Minimum Qualification (education, experience and/or training, required certifications):

  • BS or higher in Engineering Field (i.e. Chemical, Mechanical, Electrical, etc.)
  • Must be able to manage projects of varying complexity including design, construction, and qualification
  • Must be proficient in Word, Excel, and PowerPoint programs.
  • Have excellent written, verbal, and technical communication skills with the ability to independently write reports, business correspondence, Standard Operating Procedures, and presentations to effectively communicate with management and other departments
  • Ability to prioritize multiple activities and multi-task to support multiple initiatives
  • Completion of Post Offer Exam if 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 Preferences:

  • Education or experience in automation
  • Education or experience in instrumentation
  • Experience in Statistics and Statistical Process Control Capability
  • Demonstrated leadership capabilities in team environment
  • Preferred experience with process support in regulated industry

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

Tagged as: EARLY CAREER, MID TO SENIOR LEVEL

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