Computer System Validation Engineer
Bloomington, Indiana, United States
Computer System Engineer• Responsible for creating and managing new documentation for any computer systems that are out of date and/or need to be validated to keep sufficient and compliant to 21 CFR Part 11, Eudralex Annex 11. • Creating Periodic Qualification Reviews, Installation Operational Assessment, System Impact Assessment, User Requirements Specification, Traceability Matrix, Audit Trail Reviews, and Access Reviews when the system is up for review in its timeline.BIOVIA Discoverant System Owner• System Owner for BIOVIA Discoverant, in charge of creating the Hierarchy’s, database views/connections, and HTML pages for the data entry of batch records. • In charge of the co-ops for data entry tasks. Getting them trained and set up for all data entry purposes.• In charge of Weekly, Quarterly, and Annual Data pulls of batch records for clients to review.