Location: Elwood, KS
Company: Elanco
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
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. 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
never before! Here the world's brightest minds are tackling the world's biggest challenges. If you believe one person can make the world a better place, we'll put you to work. RIGHT NOW. John Deere is an equal opportunity employer. All qualified applicants will receive consideration for employment without regards to, among other things, race, religion, color, national origin, interaction, age, interactionual orientation, gender identity or expression, status as a protected veteran, or status as a qualified individual with disability.
Primary Location: United States (US) - Kansas - Coffeyville Function: Engineering (CA) Title: Engineer - Design, Manufacturing, and Quality - 102052 Onsite/Remote:
Partial Remote Position This position is eligible for a flexible work schedule arrangement at the present time. The arrangement may be delayed for training or other job acclimation purposes and remains subject to change.
Your Responsibilities As an Engineer for John Deere Coffeyville Works located in Coffeyville, KS, you will support new and current drivetrain products through design and analysis projects. In addition, you will: This position will be used to introduce engineers to several functional areas within engineering at JD Coffeyville. (Design, Quality, Manufacturing, Verification and Validation). The candidate will rotate through assignments in these areas before receiving a permanent
assignment. Provide support to current and new product programs under the guidance of lead engineers.
This may include detailed design work, test lab activity, design of tooling and/or fixtures to support factory assembly, or support of activities to ensure our products meet all customer requirements. Support transmission production operations by working cross functionally with team members to ensure successful factory operation on a daily basis. Design and/or test drivetrain components within transmission and gearboxes such as gears, shafts, castings and other components. Visa Sponsorship is NOT available for this position. What Skills You Need Basic knowledge, understanding, or awareness of drivetrain components/systems Experience with Creo or other similar 3D modeling software Experience with basic office software applications, such as Microsoft Excel, Outlook, Word, Power Point What Makes You Stand Out Understanding of engineering principles as they relate to drivetrain components Software Controls and/or coding experience through extra-curricular project team, hobby, previous work, or other Dynamics Systems Modeling experience Design or test experience or experience with virtual analysis applications/tools Internship or work experience with John Deere Experience with Six Sigma methodology or Design of Experiments Education Ideally you will have a degree or equivalent related work experience in the following: Bachelor's degree in an in Mechanical Engineering, Agricultural Engineering, Computer Engineering, or Electrical Engineering disciplines or related disciplines What You'll Get At John Deere, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment.
Here, you'll enjoy the freedom to explore new projects, the support to think outside the box and the advanced tools and technology that foster innovation and achievement.
Additionally, we offer a comprehensive reward package to help you get started on your new career path, including: Flexible work arrangements Highly competitive base pay and performance bonuses Savings & Retirement benefits (401K and Defined Benefit Pension) Healthcare benefits with a generous company contribution in the Health Savings Account Adoption assistance Employee Assistance Programs Tuition assistance Fitness subsidies and on-site gyms at specific Deere locations Charitable contribution match Employee Purchase Plan & numerous discount programs for personal use Follow this link to learn more about our Total Rewards Package bit.
ly/3XCd8f L The information contained herein is not intended to be an exhaustive list of all responsibilities and qualifications required of individuals performing the job. The qualifications detailed in this job description are not considered the minimum requirements necessary to perform the job, but rather as guidelines. The terms of the applicable benefit plans, and all company actions administering or interpreting these plans, continue to control. Deere & Company reserves the right to suspend, amend, modify, or terminate the Plan(s) in any manner at any time, including the right to modify or eliminate any cost-sharing between the company and participants.
Changes, which can be made at any time, are made by action of the company's board of directors, or to the extent authorized by resolution of its board of directors, or by the Deere & Company Compensation Committee. In the event of a conflict between the language of the official Plan Documents and this document, the language of the official Plan Documents will control. ACA Section 1557 Nondiscrimination Notice The John Deere Health Benefit Plans for Salaried Employees and The John Deere Benefit Plan for Wage Employees comply with applicable Federal civil rights laws and do not discriminate on the basis of race, color, national origin, age, disability, or interaction.
