Eli Lilly is looking for a Senior Principal Engineer - Automation Engineering to provide automation support for one or more operating areas across site and/or for capital projects, specifically focusing on Computer System Validation (CSV) for process automation systems at their new Foundry site. This role is critical for ensuring reliable and compliant control applications and systems are used in manufacturing, supporting the process control technical agenda, business plan priorities, and compliance objectives during the project delivery and startup phases.
Requirements
- Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI).
- Experience in commissioning, qualifying and supporting systems between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity
- Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity.
- Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity
- Knowledge of GMP, regulatory requirements, computer system validation
- Experience in facilitating and driving decision-making at an organizational level.
- Process control validation testing,implementation and coordination
Responsibilities
- Provide CSV support leading and executing CSV activities for process automation systems across the site.
- Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: Process Automation Systems (DCS, SCADA, BMS, MES, Historian), Building Management System, Vendor Packaged Equipment, Data Historian, Automated Storage and Retrieval System, QMS
- Perform risk assessments for computerized systems and develop strategies to mitigate identified risks
- Develop and Execute validation protocols for computerized systems
- Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity etc) and corporate Lilly quality policies and procedures
- Generate and maintain validation documentation, such as validation plans and summary reports
- Manage change control and deviation management as it pertains to CSV activities
Other
- Mentor process control team, including design, controls philosophy, implementation and commissioning
- Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
- Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement
- Demonstrated ability to influence peers and business partners
- Good written and verbal communication skills for both technical and non-technical audiences
