Eli Lilly-posted 3 months ago
$118,500 - $173,800/Yr
Full-time • Senior
Lebanon, IN
Chemical Manufacturing

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.

  • 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.
  • 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 managing CSV document relating to automation systems.
  • 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.
  • Promote the use of automation to improve productivity, operational efficiency and compliance.
  • Develop a ‘network' of corporate contacts and leveraging corporate expertise when needed.
  • Minimum B.S. in Engineering and experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical manufacturing.
  • 1-2+ years working experience in Biopharma engineering, operations, or manufacturing.
  • Expertise in GMP, regulatory requirements, computer system validation execution.
  • 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.
  • 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.
  • 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 time off and leave of absence benefits.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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