Senior Principal Engineer – Automation Engineering – CSV

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

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.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

Technical Leadership

Mentor process control team, including design, controls philosophy, implementation and commissioning

Process control validation testing, implementation and coordination

Develop and implement the Automation Engineering Project Validation Plan.

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

Develop local site procedures (e.g SOPs, Work Instructions etc) related to automation systems

Manage change control and deviation management as it pertains to CSV activities

Collaborate with vendors to ensure that third party systems and software meet validation requirements. Conduct vendor audits as needed

Provide training to personnel on CSV principles, procedures and best practices

Stay informed of industry trends (e.g CSA) and advancements in CSV and automation technologies

Represent the automation department during audits by regulatory agencies as assigned

Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems

Review and oversee the Design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution.

Lead/Participate in design reviews and Automation application software reviews to ensure compliance and standardization.

Provide periodic status updates to Project Management

Devise CSV and quality strategies for control systems in collaboration with Site Quality organization

Implement and support electronic systems (such as plant historians) used to capture process automation related production data

Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of…