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 35,000 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.

Position Brand 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 38,000 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 individuals who are determined to make life better for people around the world.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

What You’ll Be Doing:

You will be part of Tech@Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Tech@Lilly MQ strives to enable the making of medicine “with safety first and quality always".

As a Senior IT Analyst (CSV), you will be the driving force behind ensuring the compliance and reliability of our organization's computer systems. Your expertise in computer system validation will play a vital role in guaranteeing that our systems meet regulatory requirements and industry best practices, safeguarding the integrity of our operations. Join us in this crucial role where you will lead validation activities, collaborate with cross-functional teams, and stay at the forefront of technological advancements to enhance our quality and compliance standards.

How You'll Succeed:

• Lead and execute computer system validation activities in accordance with applicable regulations, guidelines, and internal procedures.

• Develop and maintain CSV documentation, including validation plans, user requirements specifications, functional specifications, validation protocols, and reports.

• Collaborate with cross-functional teams to define system requirements, identify critical functions, and establish appropriate validation strategies.

• Conduct risk assessments for computer systems to determine the level of validation effort required and develop risk-based validation plans.

• Perform gap assessments and impact analyses to ensure that validated systems meet changing business and regulatory requirements.

• Design and execute test scripts and test cases to validate system functionality, data integrity, and system security.

• Coordinate and support system change control activities, including assessing change impact, evaluating validation requirements, and implementing change controls.

• Provide guidance and expertise on CSV principles, best practices, and regulatory expectations to internal stakeholders, including IT, quality assurance, and regulatory affairs teams.

• Stay abreast of industry trends, regulatory updates, and advancements in technology to ensure continuous improvement of CSV processes and practices.

• Participate in regulatory inspections and audits, serving as a subject matter expert for CSV activities and documentation.

• Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

What You Should Bring:

• Strong knowledge of regulatory requirements, such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other relevant guidelines and standards.

• Proficiency in CSV methodologies, including risk assessment, validation planning, test script development, execution, and documentation.

• Proficiency with CSV and demonstrated ability to right-size validation based upon risk.

• Ensure compliance and inspection readiness for Data Integrity and Computer Systems across the IT computer systems used at the Concord site.

• Familiarity with a wide range of IT systems, including but not limited to enterprise resource planning (ERP), laboratory information management systems (LIMS), Laboratory Execution System (LES), manufacturing execution systems (MES), Warehouse Execution System (WES), among others.

• Excellent problem-solving and analytical skills, with a keen attention to detail.

• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

• Knowledge of project management principles and experience in managing multiple validation projects simultaneously.

• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.

Minimum Requirements:

• Minimum of 5+ years of CSV experience working in GMP regulated industry.

• Experience with IT audits, compliance assessments, and remediation activities, including addressing findings and implementing corrective actions.

Additional Preferences:

• Master’s degree in Computer Science, Information Technology, Business Administration, or a related field is preferred.

• Exposure to international operations, diverse teams, global IT projects, or working in a global organization.

• Working knowledge of IT applications and/or hardware utilized within Parenteral operations.

• Knowledgeable of Parenteral Products manufacturing and packaging.

• Working knowledge of IT Life Cycle management, IT Business Process Model, S95 model, LSEF, and other IT processes

Education Requirements:

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.

Other Information:

• Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.

• Position will be based out of the Concord, NC site with ability to travel to Indianapolis and other global Lilly sites as required

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.

#WeAreLilly

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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