Corporate Automation Computer System Validation Engineer – API Drug Substance

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:

Lilly is at a critical juncture as we tool up to realize the potential of our product pipeline. We are building new processing capabilities around the world, and emphasizing emerging, innovative processing technologies, such as continuous processing and advanced biotech platforms.

Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune five hundred company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is in the process of expanding manufacturing with three new sites in Lebanon, Indiana and recent acquisition and expansion at Kenosha, Wisconsin. In addition, Lilly announced that four new pharmaceutical manufacturing sites will be constructed in the United States that includes both active pharmaceutical ingredients (API) and parenteral manufacturing for future injectable therapies (Drug Product).

The Computer System Validation Engineer is an Engineering role that will be part of the Global Process Automation & Control Engineering team (GPACE). It will support Computer System Validation and Data Integrity processes and methods related to Lilly’s manufacturing expansion in the Active Pharmaceutical Ingredient (Drug Substance) network. GPACE is a technical resource for training, standards, capital project delivery, and Lilly’s standard automation platforms.

GPACE’s primary customers are global manufacturing and development sites, Corporate IT, Global Quality, and peer groups such as Global Facilities Delivery (GFD).

The position requires a high learning agility and experience in one or more process automation systems with a strong focus on data, systems integration, Commissioning and Qualification (C&Q) methods, architecture, and supporting automation platforms.

This role will require a strong understanding of automation/computer system validation practices, industry/regulatory knowledge in Data Integrity, and Lilly Quality Systems. The role will focus on supporting the automation team’s delivery capital projects by providing detailed strategies for automation/computer system testing and Data Integrity compliance.

Key Objectives/Deliverables:

• Be a champion for health & safety, diversity & inclusion, ethics, and compliance.
• Become a subject matter expert on Lilly Quality Standards & Procedures that apply to Process Automation systems including requirements, design, and testing with a strong focus on the API / Drug Substance network.
• Collaborate with Lilly’s Quality organization, Corporate Engineering, and GFD to develop Computer System and Process Automation qualification and testing strategies.
• Develop CSV and Verification documents and templates that can be replicated across Lilly’s API (Drug Substance) network.
• Understand and perform data integrity assessment as needed for new assets and systems.
• Drive innovation to improve the efficiency of Computer System Validation including electronic tools, AI, and new methods.
• Support CSV and Data Integrity Communities of Practice and Lillys Automation Quality Team.
• Partner with Global Facilities Delivery, Engineering firms, and site teams to develop project delivery validation plans to qualify new API pharmaceutical assets.
• Coach and mentor others.

Basic Requirements:

• B.S. Engineering (preferably in Chemical, Mechanical, Electrical, Computer) or a related science field with experience in pharmaceutical manufacturing.
• 3+ years’ experience in Good Manufacturing Practices related to API/Drug…