Senior Capital Process Engineer

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.

Position Description:

The Senior Process Engineer is responsible for supporting the design, operation, control and optimization of assets and manufacturing processes at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.  The candidate will develop a deep understanding of processes and equipment and is engaged in development, data analysis, troubleshooting, technology transfer, and continuous improvement activities.  The Senior Process Engineer plays a key role in design and delivery of local and major capital projects as well as day-to-day Process Engineering operations, acting as a subject matter expert for process and equipment.

Functions, Duties, Tasks:

Capital Project Delivery

• Provide Process Engineering support to project teams, including delivery of local and major capital projects.
• Provide Process Engineering stewardship by participating in the design, development, execution, commissioning, qualification, and validation activities for major projects.  This includes, but is not limited to; definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, support for process validation, etc. 
• Construct mass and/or energy balances for the process being evaluated.  Support definition of user requirements, equipment / facility / utility sizing and design requirements.
• Act as process and equipment subject matter expert in project teams and committees. 
• Lead and participate in process design reviews.
• Create, review and revise relevant documentation including user requirement specifications, P&IDs, PFDs, safety and environmental assessments, commissioning and qualification documents, etc.
• Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project schedule, budget and probability of technical success.
• Provide safety oversight for projects from an engineering perspective.

Process Engineering

• Provide technical support and engineering solutions for manufacturing process and equipment-related issues.
• Understand the basis for the qualification of equipment and ensure that the equipment / systems are appropriate for the intended purpose. 
• Ensure equipment and processes are operating in an expected state of control, and in alignment with regulatory commitments, GMPs and all relevant Elanco standards.
• Provide on-floor support to the Manufacturing teams regarding equipment and process troubleshooting.  Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with corrective and preventative actions assigned to return the process to a qualified state.
• Ensure changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment.  Ensure any changes are documented appropriately through the change management system.
• Use data-driven analysis of process and equipment to understand performance and capacity.  Using engineering principles, identify, recommend, and implement improvements to optimize system performance with cost and economic benefits.
• Understand process controls and be able to articulate the impact of any proposed process changes on product registration, the validated state of the process, personnel safety and potential emissions / environmental permiting.
• Ensure process operations comply with all health, safety, and environmental policies and procedures.  Lead Haz-ops and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment.
• Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures.  Exemplify “Safety First and Quality Always” mind-set.
• Attend and complete necessary training as required in order to stay current with industry standards.

Minimum Qualifications:

• Bachelor’s degree (or equivalent) in an engineering discipline (preference for biochemical / chemical engineering).
• 5+ years’ experience in pharmaceutical, biotechnology, or a related industry.
• Proven analytical thinking and problem-solving skills.
• Working knowledge of cGMP standards and/or experience working in a regulated environment.
• Demonstrated success operating in cross-functional teams.
• Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
• Strong verbal, written and interpersonal communication skills.
• Strong organizational and computer skills.

Additional Preferences:

• 8+ years’ experience in the pharmaceutical or biotechnology industry. 
• Understanding of monoclonal antibody / recombinant protein manufacturing processes.
• Experience in biological manufacturing including cell culture, purification (separation technologies, chromatography, tangential flow filtration), viral inactivation and cleaning / sterilization processes in a biological environment.
• Experience in commissioning, qualification and validation activities associated with aseptic processes, technology transfers and new product commercialization.
• Experience in capital project design, development, and execution.
• Experience with software including: SAP, ERP, AutoCAD, Veeva Vault.
• Understanding and application of RCI, FMEA and QRM tools.
• Working knowledge of USDA and/or EMA regulations for veterinary biologics.

Other Information:

• This is a full-time, permanent, salaried position.
• This is considered an on-site position.
• Day shift position.  Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
• Minimal travel requirements < 5%.

#LI-JH1

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