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.

Main Purpose and Objectives of Position

The Lab IT & CSV Professional is a member of the site IT & CSV team which has responsibility for the installation, validation and maintenance of a wide variety of computerised instrument systems in both laboratory and manufacturing areas.

The Lab IT & CSV Professional will ensure that computerised instruments systems meet all cybersecurity, data integrity, life cycle management and quality requirements.

Key Responsibilities

Responsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance)Develop in-depth knowledge of IT functionality of relevant lab equipment to aid in installation, upgrade and maintenance activitiesProvide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing , Data Migration, SOPs, Change controls and Deviation Investigations.Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc). Ensure new instrument installations and software upgrades are delivered in time to meet business needs.Lead computerised instrument upgrades and improvement projects, promoting and providing  solutions to business problems.Resolve system problems using data analysis and problem solving skills.Participate in and support audit activitiesRepresent the site and share knowledge at corporate forumsDevelop a 'network' of corporate contacts and resourcesParticipate, contribute and report at team meetings

Required Skills

Extensive knowledge and experience in development and execution of Computer system validations, in particular the laboratory systems area.Experience in administration of computerised lab equipmentDemonstrated troubleshooting ability, understanding of lab equipment software.Extensive understanding of regulatory requirements associated with CSV, including ER/ES(21CFR Part 11), security and data integrity.Demonstrated initiative to build relationships, learn new business processes and identify opportunitiesStrong leadership and influencing skills and the ability to work in cross-functional team environments, as well as independently.Strong analytical and problem-solving skills are requiredStrong written and verbal communication skills are required.

Desired Skills

Knowledge of IT infrastructure platforms and ISA S95 architectureKnowledge of Industry 4.0Project management experienceKnowledge of lab execution & LIMS systemsFamiliar with Agile methodologies

Educational Requirements:

BS in Computer Science, Engineering or related field. Comparable industry experience will also be considered.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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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