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 entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. This is an exciting once-in-a-lifetime opportunity to work in a state-of-the-art manufacturing site, in Pleasant Prairie, Wisconsin.

This facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. The Lilly Kenosha County site will leverage use of high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

As CSV Analyst, you will partner with the Site Data Leader and Site Tech@Lilly leadership to implement the computer system validation (CSV) and Data integrity strategies and culture for Site Tech@Lilly.  This role will leverage a deep understanding of CSV and Data Integrity principles ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global Tech@Lilly systems used at the Kenosha site. This role will collaborate with the local and global CSQA and Tech@Lilly organizations to enable best practices, processes, and governance and to consider new points to strengthen the Tech@Lilly CSV and Data Integrity position and align with corporate objectives and initiatives.

Key Objectives/Deliverables

• Lead and perform computer system validation projects for manufacturing and laboratory computerized instruments and systems.

• Ensure that site Computer System Inventory list is maintained and remains current.

• Author validation documentation, such as validation plans, requirements specifications, validation protocols, test plans, traceability matrices, summary reports and related change controls, ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies).

• Execute computer system validation protocols to ensure compliance and adherence with corporate guidelines and procedures, cGMP and ISPE GAMP guidelines and regulations.

• Consider the business use, data integrity, security, access, and safety for all systems undergoing validation.

• Author security administration, business continuity, and system support standard operating procedures, and audit trail review work instructions as necessary.

• Work with System Owner(s) to ensure the initiation and implementation of change control activities. Facilitate a continuous improvement culture within the areas supported.

• Investigate and resolve deviations, CAPA investigations, and other potential issues.

• Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with customers and other members of the Tech@Lilly organization.

• Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.

• Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk and follow quality management practices. Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

Basic Requirements

• Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.

• 2+ years of relevant work experience in information technology, engineering, computer system validation, quality control support or related areas.

• Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.

• Solid knowledge of Computer System Validation process.

Additional Preferences

• Master’s degree in Software Engineering, Computer Science, Com