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IT Specialist
2 weeks ago
Laboratory IT and CSV Professionals play a crucial role in ensuring the seamless integration of computerised instrument systems within laboratory settings. At Eli Lilly and Company, we are seeking an exceptional individual to join our team as a Computerized Instrument Professional.
The successful candidate will be responsible for guaranteeing that computerized instrument systems meet all relevant regulatory requirements, company policies, and procedures. This includes driving improvements aligned with regulatory changes, such as 21 CFR Part 11, EU GMP Annex 11, and Data Integrity Guidance.
A key responsibility of this role is to develop in-depth knowledge of IT functionality relevant to lab equipment, which will aid in installation, upgrade, and maintenance activities. The professional must also provide technical oversight for computerised instrument validation processes, adhering to site and corporate procedures, as well as GMP guidelines.
Additionally, this position entails managing, coordinating, developing, and executing computer system validation deliverables for new and existing projects. This includes creating project plans, prioritizing validation activities according to overall project schedules, and liaising with vendors to design and deploy computerised instrument solutions that integrate with existing onsite IT services and infrastructure.
The ideal candidate should possess extensive knowledge and experience in development and execution of Computer System Validations, particularly in the laboratory systems area. They should also have experience in administration of computerised lab equipment, demonstrated troubleshooting ability, and understanding of lab equipment software.
