Sr. Director - Automation Engineering - Lilly Medicine Foundry

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 100,000 - 160,000; Full time

Job summary

An established industry player is seeking a Senior Director of Foundry Automation Engineering to lead the automation engineering function at a groundbreaking facility. This role involves designing an organization that meets the highest standards of safety and quality while driving innovation in manufacturing processes. The successful candidate will collaborate with various teams to ensure project deliverables align with long-term strategic goals. This is a unique opportunity to shape the future of automation in a state-of-the-art environment, where your expertise will directly contribute to life-changing solutions in the healthcare sector.

Qualifications

• Minimum 7 years of experience in regulated industry required.
• Experience with automation platforms is essential.

Responsibilities

• Design and build the automation engineering organization for the facility.
• Ensure compliance with corporate standards for automation engineering.

Skills

Automation Engineering

Project Management

Collaboration

cGMP Knowledge

Technical Leadership

Education

Bachelor's degree in Engineering

Tools

Automation Platforms

Job description

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.

Overview:

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 Director Foundry Automation Engineering provides administrative and technical leadership for the automation engineering function and is a member of the Foundry Site Lead Team (FLT). The FLT has collective responsibility to develop and implement the strategic direction, organizational capability and management of the site. Primarily, the members of the team drive the site toward achieving long-term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate and LRL objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate/external context.

In the Project Delivery Phase and Startup Phase of the project (2025 To 2028), the FLT 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 Lilly Medicines Foundry goes from design, to start-up, and to steady-state operations.

Responsibilities:

• Design and build the automation engineering organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
• Define the automation engineering priorities and roadmap to develop and implement the systems and processes needed to run the site. This includes leveraging existing Lilly knowledge where necessary but also incorporating external learning and design or adoption of novel solutions.
• Demonstrate knowledge and ability to derive solutions that combine internal technologies and/or partnered solutions to augment capabilities required for a complex multi-modality site as is in the Foundry.
• Support the project team to deliver the automation for the facility as the end user providing feedback and support on design decisions, commissioning strategies, startup plan, etc. Collaborate to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
• Develop and adapt organizational structure to provide correct and capable automation resources and management to deliver the site.
• Ensure the automation systems are in place and executed to establish the initial qualified and safe state for equipment and processes across small molecule, hybrid and biologics.
• Build technical relationships with the relevant corporate departments and sponsors strategic corporate initiatives at a site level. Successfully partner with Tech@Lilly, GFD, ETC, and other peer groups to deliver automation solutions and platforms for the Foundry.
• Manage discipline and technical excellence - understand the state of the discipline and develop strategies for both people and processes to close gaps. Support the development and maintenance of engineering requirements (Standards, Patterns, Master Specifications), best practices and technical reports.

Post Startup:

• Continue to define and support the automation engineering priorities and roadmap; integrate the functional agenda with site priorities.
• Ensure the site is in compliance with corporate standards and policies for the automation engineering function, including applicable environmental, safety, and quality requirements.
• Have external focus and benchmark best practices across Lilly and externally.
• Ensure automation processes remain and operate in a qualified and safe state; Ensure that equipment maintenance are performed and documented to the highest standards of safety and quality.
• Manage the site investment processes for automation related assets (planning, prioritization, resourcing, project management, capital accounting and reporting).
• Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and maintained.
• Develop the future automation management and technical leadership for the site and for potential manufacturing and PR&D assignments.
• Collaborate with the Engineering Tech Center and Tech@Lilly to implement a comprehensive Cyber Security Strategy for PR&D.

Requirements:

• Minimum of a Bachelor's degree (or equivalent) in an engineering discipline and a minimum of 7 years of experience within the regulated industry.
• Experience with one or more automation platforms.

Additional Preferences:

• Must possess knowledge and understanding of cGMPs and how they apply to process engineering and operations.
• Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the FLT to ensure alignment with corporate objectives and internal decision making processes and be able to connect and communicate effectively with all levels of the organization on site.
• Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
• Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.
• Proven record of developing and deploying novel automation technologies in the pharmaceutical industry.

Other Information:

• Initial location at Lilly Technology Center, Indianapolis.
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.