Manufacturing Process Engineer – Night​/Day Shift

Manufacturing Process Engineer – Night & Day Shift

The Manufacturing Process Engineer is responsible for supporting the design, operation, control and optimization of assets supporting technical processes at Elanco's Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to the process and equipment and is engaged in development, data analysis, troubleshooting, technology transfer, and continuous improvement activities. The process engineer plays a key role in day-to-day operations, change/deviation management, process improvements, and delivery of capital projects.

Your Responsibilities:

• Provide Technical and On-Floor Support for Process and Equipment:
  Deliver robust engineering support for both routine operations and capital projects by troubleshooting equipment and process issues, offering on-floor assistance to manufacturing teams, and ensuring that all problems are promptly documented in the quality management system. Apply thorough root cause analysis and implement appropriate corrective and preventive actions to ensure operational reliability.
• Ensure Equipment Qualification and Compliance:
  Maintain the qualified state of process equipment by ensuring all systems are fit for their intended use, compliant with cGMP standards, Elanco policies, and regulatory requirements. Provide oversight during interventions, maintenance, and changes, ensuring all activities are properly documented and managed through formal change control procedures.
• Drive Performance and Process Optimization Through Data Analysis:
  Leverage data-driven insights to monitor equipment and process performance, evaluate system capacity, and identify opportunities for continuous improvement. Recommend and implement enhancements to optimize productivity, reduce variability, and ensure consistent system control.
• Lead and Support Full Lifecycle of Capital Projects:
  Actively contribute to the design, development, execution, commissioning, qualification, and validation of major capital projects. This includes defining project scope, evaluating design alternatives, selecting equipment, developing user requirements, overseeing construction, and supporting process validation activities to ensure successful project delivery.
• Develop and Manage Technical Documentation and Risk Mitigation Strategies:
  Prepare, review, and update key documentation such as user requirement specifications, process and instrumentation diagrams (P&IDs), safety and environmental assessments, and qualification protocols. Collaborate cross-functionally to identify risks, drive value engineering, and enhance the technical and financial success of projects.

What You Need to Succeed (minimum qualifications):

• Bachelor's degree in Chemical, Biological or related engineering discipline
• Experience in pharmaceutical, biotechnology, or a related/relevant industry
• Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision with a working knowledge of cGMP standards and/or experience working in a regulated environment and success working in cross functional teams

What will give you a competitive edge (preferred qualifications):

• 2+ years' experience in pharmaceutical, biotechnology, or a related industry
• Experience in capital project design, development, and execution
• Understanding of monoclonal antibody / recombinant protein manufacturing processes
• Experience with SAP EAM, ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, Meridian
• Understanding and application of RCI, FMEA and QRM tools
• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics

Additional Information:

• Location:
  
  Elwood, KS (60 min north of Kansas City, MO; 10 min from St. Joseph, MO)
• This is a salaried day shift position. Weekend work is required on a rotation to provide process support to ongoing operations.
• Shift
  
  Schedule:
  
  Approximately 5:30pm - 2:00am

Don't meet every single requirement? Studies have shown under-represented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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:

• Relocation packages
• Two-week shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 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