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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Responsible for administration of Automated system software to meet end-user needs regulatory expectations and established SOP's.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Administer user access - Control access to software systems; add, modify and remove users; define user types, user groups and security settings.
* Ensure systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO. Perform recovery of data as needed.
* Configuration management and recipe/method management.
* 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 systems with other systems (ex. LIMS, Historian) as required by business needs.
* Draft, approve and follow relevant system software SOPs and policies.
* Train end-users on basic system functionality.
* Provide end-user support including troubleshooting problems at the application level and basic hardware troubleshooting (includes working with vendors to resolve issues).
* Support/Lead written investigations of abnormal events, root cause analysis, corrective or preventative actions, and system review/assessments.
* BS/BA in Science/Engineering or related field preferred along with 2 years of relevant experience in manufacturing/lab/IT setting; will consider minimum 5 years of relevant experience in manufacturing/lab/IT setting in lieu of educational requirement. Experience with Empower is strong preferred.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.