Associate Director - Automation Engineering – Control System Validation And Data Analytics

Associate Director-Automation Engineering – Control System Validation And Data Analytics

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 Associate Director-Automation Engineering – Control System Validation and Data Analytics, is responsible for the supervision of the Automation Engineering CSV and data engineers that support the daily operations of the facility. The Associate Director is also responsible for the productivity and development of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Associate Director partners to influence and implement within the process control 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), leadership 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.

Key Objectives/Deliverables:

• Administrative Leadership

• Supervise and coach process control team, including completing performance reviews and development plans.

• Staffing, including recruiting, resource planning, and succession planning.

• Process validation and CSV work coordination.

• Review and monitor financial performance; commit to meeting targets.

• Develop and implement the Process Control Validation Plan, Quality Documents, SOP's and Audit Readiness.

• Develop the Data Analytics capability to provide site support for site metrics and visualization.

• 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

• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity etc) and corporate Lilly quality policies and procedures.

• Maintain validation documentation, such as validation plans and summary reports.

• 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.

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

Operational Excellence

• Demonstrate a commitment to environmental, health, and safety.

• Identify, track, and report key indicators of functional performance.

• Ensure team is operating in a state of compliance.

• 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.

• Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated documentation.

• Automation support for capital projects including new product introductions.

• Promote the use of automation to improve productivity, operational efficiency and compliance.

• Develop a 'network' of corporate contacts and leveraging corporate expertise when needed.

Organizational Capability

• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.

• Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting.

• Ability to instill teamwork within the department and demonstrate key interpersonal skills.

• Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.

• Ability to make decisions independently and to network with others as appropriate.

• Ability to function in a team environment as a leader and as a member of management teams.

• Ability to influence peers and business partners.

Basic Requirements:

• Minimum B.S. in Engineering and experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical manufacturing.

• 12+ years working experience in Biopharma engineering, operations, or manufacturing.

• Expertise in GMP, regulatory requirements, computer system validation execution.

Additional Preferences:

• 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, Power BI, QMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, Veeva, Analysis tools, OSI PI).

• Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity.

• Experience in design and development of data analysis and data contextualization to support site functions and metrics.

• Experience as a member of the group leadership in running the plant, including participation in management sub-teams.

• Successful application of organizational models through recruiting and retention of employees.

Other Information:

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

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain