Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Responsible for administration of laboratory system software to meet end-user needs and regulatory expectations and established SOP's.
Essential Duties and Responsibilities include, but are not limited to, the following:
•Administer user access - Control access to software systems; add, modify and remove users; define user types, user groups and security settings.
•Ensure lab systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO. Perform recovery of data as needed.
•Monitor systems configuration to ensure data integrity and 21CFR11 compliance.
•Contribute to system validation and qualification efforts.
•Ensure systems remain in compliant state - Process change control requests for system configurations, including requirement and/or design specifications and test plans.
•Assist in integrating lab systems with other systems (ex. LIMS, Historian) as required by business needs.
Education and Experience:
BS/BA in Science, Engineering or related field preferred along with 3 years of relevant experience in a lab or IT setting. Will consider a minimum of 5 years relevant experience in a lab or IT setting in lieu of educational requirement.
Regeneron is an EEO employer.