Associate Director Engineering - Kneat & Batascript

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.

Position Brand Description:

The Digital Engineering Platforms team supports the delivery and continuous improvement of key systems and tools that enable efficient engineering, maintenance and facility operations across Lilly’s global network. The team partners with site-based engineers, project teams, Quality and global functions to ensure these platforms are effective, user-friendly, and aligned with business needs.

This role provides global ownership for two critical digital systems: Kneat , used for managing validation and compliance documentation, and Batascript, used to track and document fit and finish compliance and improvements in pharmaceutical manufacturing buildings. The individual in this role will lead system strategy, support global adoption, drive continuous improvement, and serve as the primary point of contact for issue resolution, enhancements, and stakeholder engagement.

Key Objectives / Deliverables

1. Global Business Subject Matter Expert (Kneat & Batascript)

• Serve as the global business subject matter expert for both Kneat and Batascript, ensuring each system is aligned with business needs, easy to use, and continuously improved.
• Lead the Kneat Community of Practice (KCOP) and act as the primary advisor to Lilly sites, global programs, and Power User SMEs.
• Own and maintain global SOPs, training content, and user guidance documents for both systems to support effective, standardized use.
• Manage the Kneat DEV instance to support training, testing, and development initiatives.
• Create and maintain comprehensive training materials for Batascript users and support site-level adoption.
• Lead or support global process improvement initiatives to enhance the efficiency and value of Kneat and Batascript.
• Partner with Kneat Solutions, Inc. to influence product roadmaps and ensure Lilly's priorities are addressed.
• Participate in external consortiums and forums to represent Lilly, benchmark best practices, and influence the future of electronic validation and facility documentation tools.

2. Global System Owner (Kneat & Batascript)

• Serve as the global system owner for both Kneat and Batascript, ensuring the systems are maintained in a validated, compliant, and high-performing state.
• Participate in the Kneat Core Team and Kneat Steering Team to guide strategic decisions and roadmap alignment.
• Approve Computer System Validation (CSV) deliverables as required by LQS302 and ensure change controls are appropriately managed for both systems.
• Oversee and coordinate system updates, enhancements, and change management activities for Batascript, ensuring user needs and regulatory expectations are met.
• Monitor system usage and performance metrics to identify opportunities for optimization and scalability.

3. Maintain ‘Right-to-Operate’

• Ensure both systems meet all regulatory, quality, and corporate policy requirements, maintaining validated states and audit readiness.

Minimum Requirements

• Bachelor's Degree in Engineering or equivalent Work Experience (10+ years)
• Minimum of 5 years of experience in pharmaceutical process development, manufacturing, or related technical roles
• Familiarity with or experience in validation practices, including equipment commissioning, qualification, or computer system validation (CSV)
• Demonstrated ability to collaborate cross-functionally in a regulated environment
• Experience supporting or leading digital system implementations or business process improvements

Additional Preferences

• Strong written and verbal communication skills
• Ability to work independently with minimal supervision
• Comfortable operating in a cross-functional, team-based environment
• Project management experience, including the ability to manage timelines, system updates, and stakeholder engagement
• Familiarity with Kneat and/or Batascript systems, or similar electronic documentation and validation platforms
• Experience supporting or managing digital tools in a regulated pharmaceutical or manufacturing setting

Other Information: