Job Description:Your day-to-day will include:- 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.
You have the following technical skills and qualifications:Requirement - Master's degree in Engineering Management, Engineering Technology, Industrial Engineering, a related field, or a foreign equivalent.
Relevant experience - Applicants must have 1 year of experience in the following: (1) biological/pharmaceutical manufacturing including mAb immunotherapy and parenteral drug manufacturing; (2) Manufacturing and manufacturing facility equipment commissioning and qualification (including single use bioreactors, chromatography, TFF, and sterile liquid filling equipment); (3) Data trending of process data from site and equipment historians; (4) cGMP and regulated environments and compliance with regulations in a clean room environment; (5) Training, change management, document modification and creation; and (6) interpretation o
