Job Description
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana.
We are looking for a Lab IT & CSV Professional to join our site IT & CSV team. This team is responsible for the installation, validation, and maintenance of computerized instrument systems in laboratory and manufacturing areas.
Main Responsibilities
* Evaluate computerized instrument systems to ensure they meet all cybersecurity, data integrity, life cycle management, and quality requirements.
* Develop knowledge of IT functionality of relevant lab equipment to aid in installation, upgrade, and maintenance activities.
* Provide technical oversight for computerized instrument validation processes, including Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls, and Deviation Investigations.
* Manage and execute computer system validation deliverables for new and existing projects, including project plans, prioritizing validation activities, and coordinating with vendors.
* Resolve system problems using data analysis and problem-solving skills.
Requirements
* Extensive knowledge and experience in development and execution of Computer System Validations, particularly in the laboratory systems area.
* Experience in administration of computerized lab equipment.
* Demonstrated troubleshooting ability, understanding of lab equipment software, and extensive understanding of regulatory requirements associated with CSV.
* Strong leadership and influencing skills, as well as the ability to work in cross-functional team environments and independently.
* Strong analytical and problem-solving skills, along with strong written and verbal communication skills.
Educational Requirements
A BS in Computer Science, Engineering, or a related field. Comparable industry experience will also be considered.