Primary Loop Process Engineer

Elanco•Elwood, KS

7d•Onsite

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Requirements

Master’s degree in Engineering Management, Engineering Technology, Industrial Engineering, a related field, or a foreign equivalent.
1 year of experience in biological/pharmaceutical manufacturing including mAb immunotherapy and parenteral drug manufacturing.
1 year of experience in Manufacturing and manufacturing facility equipment commissioning and qualification (including single use bioreactors, chromatography, TFF, and sterile liquid filling equipment).
1 year of experience in Data trending of process data from site and equipment historians.
1 year of experience in cGMP and regulated environments and compliance with regulations in a clean room environment.
1 year of experience in Training, change management, document modification and creation.
1 year of experience in interpretation of 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

Responsibilities

Provide technical support and engineering solutions for process and equipment-related issues including delivery of local and major capital engineering projects.
Utilize understanding of engineering principles, as well as his knowledge regarding the basis for the qualification of equipment and ensure that the equipment/ systems are appropriate for the intended purpose.
Utilize engineering knowledge to 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 guidance to Manufacturing teams regarding equipment and process troubleshooting.
Ensure engineering issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
Utilize knowledge of engineering technology and principles to 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 to engineering processes are documented appropriately through the change management system.
Utilize data-driven analysis of engineering processes and equipment to understand system and process performance and capacity.
Identify, recommend, and implement engineering improvements to optimize system performance.
Participate in the design, development, execution, commissioning, qualification, and validation activities for major projects. This will include, 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, and support for process validation.