DUTIES: Responsible for supporting the operation, control and optimization of manufacturing assets and technical processes at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. 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 plus 1 year post-baccalaureate experience in job offered or any research scientist related job titles. • Applicants must have 1 year of experience in the following: (1) Working in medical device, pharma, or biotechnology, industry; (2) Installation Qualification (IQ), operational qualification (OQ), Validation, and Installation; (3) cGMP standards and experience working in a regulated environment; (4) GMP documentation, Safety, Standard Operating Procedures (SOP), Batch Documents, Change Control, Protocol Execution, and Deviation investigation; (5) Statistical Process Control (SPC) to monitor and control process parameters and for internal corrective actions; (6) development and analysis of design scope for manufacturing equipment; and (7) providing maintenance guidance for manufacturing equipment. • undefinedJOB SITE: 1411 Oak Street, Elwood, KS 66024 SALARY: $98,234 - $150,300 per year Submit resumes for Consultant - Manufacturing Engineer (REQ) via: https://www.elanco.com/us/careersAny person may provide documentary evidence bearing on the application to the Certifying Officer of the Department of Labor at the following address:Certifying OfficerU.S. Department of LaborEmployment and Training AdministrationOffice of Foreign Labor Certification200 Constitution AvenueNW, Room N-5311Washington, DC 20210Phone: (404) 893-0101Fax: (404) 893-4642 This notice was posted for at least ten consecutive business days in the internal electronic media of Elanco US Inc.