Senior Principal Engineer - Automation Engineering – CSV

The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life-changing products at the new site.

The Senior Principal Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing itionally, the Senior Principal Engineer is a key technical expert with partners to influence and implement within the Automation Engineering organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity etc) and corporate Lilly quality policies and procedures
• Collaborate with vendors to ensure that third party systems and software meet validation requirements. Conduct vendor audits as needed
• Review and oversee the Design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution.
• 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
• Knowledge of GMP, regulatory requirements, computer system validation
** Basic Requirements:*
* • Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling System integration of applications, systems and platforms
• 8+ years working experience in Biopharma engineering, operations, or manufacturing.
• Knowledge of GMP, regulatory requirements, computer system validation
• Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity
• Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (Delta

V, Rockwell, Syncade, Lab Vantage, 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.
• Experience in facilitating and driving decision-making at an organizational level.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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