Company Overview Elanco, the Animal Health Division of Eli Lilly, is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana. Responsibilities The Sterile Filling Engineer is responsible for supporting the start-up and daily production of the site’s new Sterile Pre-Filled Syringe line. The Filling Process Engineer will also be responsible for implementing process improvements, provide technical leadership and expertise for production operations in the areas of: Process and Equipment Qualification, Improving the Manufacturing and Business Processes, Process Safety Management, and Adherence to Business systems. The Process Engineer is considered the owner for the process equipment and ensures proper care and maintenance practices are being followed to maximize the equipment performance and life.Functions, Duties, Tasks:

  • Ensure equipment is commissioned and qualified to meet all safety, compliance, and operational objectives.
  • Provide over site and ownership for the development of key operational procedures and training material.
  • Primary process owner at the unit operations level, integrating process and equipment knowledge.
  • Monitor established control systems for process indicators to identify and follow-up on significant issues.
  • Utilize formal problem solving techniques, including root cause analysis, to resolve issues leading to production delays.
  • Own equipment-related deviation investigations, corrective/preventive actions, and changes.
  • Perform equipment periodic reviews and maintain the qualified state of systems supported.
  • Develop control systems to monitor and identify gaps in process team performance metrics.
  • Identify better equipment/unit operations technologies.
  • Technical expert/support for installation and maintenance of process equipment.

  • Transfer knowledge of equipment capabilities and operational techniques to operations and maintenance Improving the Business or Process

  • Develop/maintain process team project improvement activities for capacity (yield, cycle time, cleaning, etc.); product quality, raw material cost, waste loads, process variability, equipment reliability and process safety.
  • Perform and summarize improvement opportunities in technical reports through statistical analysis, plant trials, investigations, and process/unit operations modeling.
  • Analyze and document incident common causes on process team.
  • Understand process/unit capacity constraints, and identify projects to prevent conflicts.
  • Lead or participate in Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) activities (including commissioning activities of new equipment or areas).
  • Develop proposals to close identified gaps for process, unit, and site metrics and other business units.

  • Develop capital project business cases and act as user representative for capital projects or delivery agent for local projects Process Safety Management

  • Provide the technical leadership and problem solving skills for Safety and Process Safety incident investigations.
  • Performs compliance related technical tasks such as emissions calculations, equipment evaluation, and application of material balances for environmental needs.

  • Leads and/or participates in process hazard reviews and other process safety activities. Serves as main resource for process safety issues on supported processes Adherence to Business Systems

  • Manage the implementation of countermeasures arising from deviations, spills, and safety related events.
  • Manage the implementation of recommendations from PHRs and other audit findings.
  • Maintains and analyzes process team metrics including cycle time, change overs, etc.

  • Maintain and establish the technical information for the processes Basic Qualifications

  • Bachelors Degree in Engineering or related degree
  • 2 years’ experience in an engineering, maintenance or technical support area

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

  • Technical knowledge of chemical processing and process equipment and understanding of production scale unit operations.
  • Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement.
  • Ability to function in a team environment as a leader and as a member of teams
  • Understanding of and experience with sterile filling lines.
  • Understanding of and experience with pharmaceutical cGMPs and their application to work processes.
  • Understanding of and experience with automated processes. Familiarity with Distributed Control Systems (DCS) (i.e. DeltaV, PRoVOX, etc.) and/or Programmable Logic Controller (PLC) systems.
  • Ability to work effectively with other plant functions, including Tech Service/Manufacturing Sciences, Automation, Maintenance and Reliability, Quality Assurance, Quality Control, Project Engineering, Validation, and Logistics.
  • Expertise in root cause analysis tools (e.g. Causal Factor Charting, Fishbone Diagram, Fault Tree Analysis, Failure Mode and Effects Analysis (FMEA), etc.)
  • Lean and/or Six Sigma experience.
  • Strong written and oral communication skills. Ability to communicate effectively with all levels of the organization from plant management to operations specialists.
  • Excellent organizational, project, and time management skills. Ability to effectively manage and prioritize competing priorities and to handle change productively.
  • Process hazard identification and mitigation skills.

  • Strong computer skills in various software packages (Microsoft applications, Aspen Process Explorer, etc.) Additional Information

  • Shift is normally 8 hours per day. Different coverage hours may be required to support a 24/7 operation. The incumbent is expected to respond to plant emergencies when required.
  • Role will require utilization of personal protective equipment (PPE) at times.
  • Little to no travel is required for this position.
  • Lilly 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.

Desired Skills and Experience

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