IT Analyst - CSV

Lebanon, IN, United States

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.

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, and start up the facility for both clinical and commercial supply.

This role will provide CSV technical leadership across the different IT groups in Lilly Lebanon focused on external regulations, industry best practices, policies and procedures governing the process to validate, maintain and retire new and existing computer systems. The position will be responsible for defining and maintaining CSV local policies and procedures to ensure that all solutions deployed are developed and implemented according to enterprise policies and regulatory requirements.

This role will collaborate within the Lilly Tech at Lilly and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems.

Responsibilities:

Oversight and support of computer systems validation activities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate

Provide input and execute the risk management approach for CSV for the Lilly Lebanon sites.

Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements

Support Data Integrity readiness for regulatory authority inspections at the Lilly Lebanon site and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity.

Anticipate short term and future needs of the function to focus. Enable and influence business effectiveness by identifying opportunities for leveraging technology

Maintain the organization's System Development Life Cycle (SDLC) ensuring that current business and regulatory requirements are satisfied. Establish a framework to monitor and audit adherence to SDLC.

Collect, evaluate and prioritize opportunities to improve compliance, privacy, and SDLC related policies and procedures. Report, analyze, audit and develop plans and programs to support continuous quality improvement.

Participate in business plan activities and in appropriate site governance and steering teams.

Help determine the GMP designation and testing requirements for analytics tools.

Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements

Must ensure security and privacy risks are considered in the design and testing of IT systems

Basic Qualifications: Bachelor's Degree in relevant fields such as Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent

Additional Preferences: Experience working in a regulated industry (i.e. GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution

Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions

Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership

Strong collaboration with colleagues at all levels

Demonstrated courage & integrity

Demonstrated success in influencing without authority

Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships

Highly flexible, adapting to changes in priorities, requirements and processes is required.

Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment

Demonstrated ability to interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills

Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems

Recognized understanding of regulations governing CSV and data integrity

Speak up with ideas as well as concerns and ensure the psychological safety of others.

Demonstrated learning agility and ability to think creatively; try new ideas and apply learnings.

Business acumen, and the ability to communicate to executives, business domain stakeholders and technical staff alike

Experience with innovation and ideation methods, such as design thinking.

System integration experience, including interface design, and familiarity with web-oriented architecture techniques

Understanding of common information architecture frameworks and information model

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 ( [email protected] ) 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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