Engineer Automation CSV and Data Integrity

Eli Lilly and Company
Published
October 15, 2020
Location
Indianapolis, IN
Category
Job Type

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 39,000 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.

Responsibilities :

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, biotech platforms, and advanced data and control systems.  Additionally, we are recapitalizing older assets, and bringing the operational philosophies in line with current technologies.  Lilly places a high value on fully automated manufacturing processes, as the quality and operational benefits are baseline expectations of new process design. 

Global Process Automation & Control Engineering (GPACE) is part of the Engineering Tech Center (ETC).  GPACE provides automation, measurement, cyber-security, and process control solutions.  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, MQ-IDS (Information & Data Solutions), Corporate InfoSec, Global Computer System Quality (CSQA) and peer groups such as Global Facilities Delivery (GFD). 

 The Process Automation Computer System Validation and Data Integrity Engineer is an Automation Engineering role, which requires a 4-year engineering degree, preferably in Chemical, Mechanical, Electrical, Computer, or a related science field.  This role will be the process automation corporate engineering Computer System Validation/Data Integrity lead and will support Lilly facilities globally working closely and collaboratively with MQ-IDS and Global Quality.  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 also support automation team’s delivery capital projects and provide guidance on automation/computer system testing and Data Integrity Assessments. 

Key Objectives/Deliverables 

  • Work safely and continually look for improvements to both people and equipment safety. 
  • Provide corporate engineering leadership to Data Integrity programs, new asset DI assessments, and develop best practices and standards to support manufacturing and major capital project delivery. 
  • Provide Process Automation reviews and influence Global Quality Procedures that impact computer systems and automation platforms. 
  • Develop and lead a community of practice for our manufacturing sites for Data Integrity and CSV programs. 
  • Develop templates and standards for Verification (formerly known as Commissioning and Qualification). 
  • Innovation - Evaluate new technologies for Verification such as electronic testing systems. 
  • Provide quality oversight to GPACE central solutions and libraries. 
  • Own Global Engineering Best Practices for Manufacturing on Data Integrity Information Classification

Basic Qualifications :

  • BS in engineering or related science field.
  • 3+ years’ experience in process automation engineering, preferably supporting a manufacturing site.
  • 3+ Years of experience in one or more process automation platforms demonstrated with work experience and/or training.
  • Experience working in a regulated industry

Additional Skills/Preferences :

  • Experience in pharma or GMP industry
  • Experience in commissioning and qualification
  • Experience working with validated systems
  • Expertise in Lilly’s preferred platforms, including Rockwell Automation, Emerson DeltaV, Foxboro, and Microsoft Operating Systems.
  • Ability to work well with different cultures and engineering disciplines internationally
  • Knowledge in Historians, and IT platforms such as servers, and workstations.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [Click Here to Email Your Resumé] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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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