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 (m Ab) 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 backssments, 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, c GMP 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 medical, biotechnology, or a related industry. Proven analytical thinking and problem-solving skills.
Working knowledge of c GMP 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 medical 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, Auto CAD, 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
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. Why Work at Elanco? We Save Puppies! Working at a monoclonal antibody start-up facility in Elwood, Kansas presents an exciting opportunity to contribute to cutting-edge research: Monoclonal antibodies are an innovative type of biologic drug that can target specific molecules in the body to treat a variety of diseases, including cancer and autoimmune disorders.
Working at a start-up facility that is developing and manufacturing these drugs at a commercial scale is an opportunity to be on the forefront
of medical research and contribute to developing treatments that can have a significant impact on pets' lives. Our newest product is a one-time injection that is 100% effective in curing the deadly parvovirus in puppies!
Elwood is 60 min North of downtown Kansas City and 15 min from St. Joseph, MO. Summary: This Position has the responsibility of providing technical knowledge and assistance to management and personnel of the labeling and packaging, label control, filling, maintenance, product supply, quality assurance, change management, TSMS, shipping & warehousing, regulatory affairs, R&D and sales and marketing departments. The Position also executes the capital plan for small and
large scale equipment expansion/upgrade projects in line with the strategic plan of the company; including purchase and installation of labeling and packaging equipment and improvement of processes.
Responsibilities: Provide labeling and packaging materials and processes technical knowledge to develop and specify printed packaging materials (PPMs) and create specifications and templates for PPMs. Provide technical knowledge of primary, secondary, and tertiary packaging materials to develop and specify packaging materials and create specifications for such materials. Provide packaging engineering knowledge and support to labeling and packaging, label control, filling, supply planning, TSMS, sales and marketing, R&D, maintenance and quality assurance departments.
Provide technical knowledge for investigation and remediation of material quality issues and product quality complaints associated with labeling and packaging, label control, filling, supply planning and shipping & warehouse departments. Interface with PPM and primary, secondary and tertiary packaging material suppliers to prevent, correct and resolve material quality and supply issues. Interface with product managers, sales and marketing, quality assurance, filling, packaging and labeling, regulatory affairs and R&D personnel.
Design and develop new product presentation packaging materials. Maintain uniformity of materials to minimize change-over time on packaging lines. Follow industry trends to propose and implement new and improved packaging materials and processes to improve packaging and labeling efficiency and equipment utilization. Provide engineering support in development of equipment specifications, (URS, functional specification, detail design) for small and large scale equipment projects. Work with end-users and stakeholders to develop a successful URS to facilitate the project.
Work with vendors and stake holders on design, installation, commissioning, factory acceptance test, startup, and validation of equipment and facility. Design, planning, document review; ensure right first time, successful startup of new or improved equipment. Review proposals, documents to verify adherence to project scope and technical expectations. Projects are completed with the budget funding. Support development of capital budget for equipment upgrades and modifications. Provide input into the capital plan with regards to labeling and packaging department needs.
Minimum Qualifications: Bachelor of Science Degree in Engineering or five years’ experience in packaging engineering role. Technical knowledge of PPMs and primary, secondary and tertiary packaging materials Knowledge of c GMPs for vaccine/medical production processes Excellent written and verbal communication skills Attention to detail and commitment to customer service. Ability to plan, schedule, organize, prioritize, and coordinate project activities as activities impact strategic and operation strategies Ability to understand, evaluate, and implement validation strategies in tandem with project activities.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, interactionual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Engineering jobs encompass a vast array of specialized roles within the field of engineering, aimed at designing, developing, and maintaining various technological systems and structures. These roles typically require a strong foundation in mathematics and science, and they span across numerous sectors such as civil, mechanical, electrical, and software engineering, among others. The key features of engineering careers include problem-solving, innovation, and the application of practical knowledge to create solutions that can improve people's lives, enhance business operations, or even address global challenges. Engineers often work in teams, collaborate with other professionals, and are at the forefront of technological advancement.
