Consultant – Manufacturing Engineer
Elanco
Summary
Responsible for supporting the operation, control and optimization of manufacturing assets and technical processes at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.
Job description
Act as 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.
Play a key role in day-to-day operations as well as local and major capital project equipment design, installation, commissioning, qualification and validation.
Provide technical support and engineering solutions for process and equipment-related issues including delivery of local and major capital projects.
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 appropriate corrective and preventative actions assigned.
Ensure equipment and processes are operating in an expected state of control, and in alignment with regulatory commitments, GMPs and all relevant Elanco standards.
Ensure changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment.
Ensure changes are documented appropriately through the change management system.
Use data-driven analysis of process and equipment to understand performance and capacity and identify, recommend, and implement improvements to optimize system performance.
Participate in 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.
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.
Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and technical success.
Create, review and revise relevant documentation including user requirement specifications, P&IDs, PFDs, safety and environmental assessments, commissioning and qualification documents.
Manage Quality events as assigned – Deviation, Change Control, CAPA etc.
Prepare change management plans and complete corresponding action items.
Understand the basis for the qualification of equipment and ensure that the equipment / systems are appropriate for the intended purpose.
Requirements
- Master’s degree in Engineering Management, Mechanical Engineering, a related field, or a foreign equivalent
- 1 year post-baccalaureate experience in job offered or any research scientist related job titles
- 1 year of experience working in medical device, pharma, or biotechnology industry
- 1 year of experience with Installation Qualification (IQ), operational qualification (OQ), Validation, and Installation
- 1 year of experience with cGMP standards and working in a regulated environment
- 1 year of experience with GMP documentation, Safety, Standard Operating Procedures (SOP), Batch Documents, Change Control, Protocol Execution, and Deviation investigation
- 1 year of experience with Statistical Process Control (SPC) to monitor and control process parameters and for internal corrective actions
- 1 year of experience with development and analysis of design scope for manufacturing equipment
- 1 year of experience providing maintenance guidance for manufacturing equipment
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.