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Job Discription
Regeneron Pharmaceuticals, Inc. seeks a Senior IT Analyst (Troy, NY) to lead system integrations & system validations incl development of validation documentations and creation/modifications of SOPs and Technical assessments for the U.S. and E.U. Requires Bachelor’s degree in Information Systems, MIS, or closely related degree and 4 years of experience in IT implementation projects, including integration technologies and business process automation. Must have 4 years of experience gathering business, data and FDA regulatory requirements and develop User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and System Design Specifications. Must have 2 years of experience with: validation of the Tracelink Life Sciences Cloud system, with partners, vendors and regulatory organizations including generating and executing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test protocols; gathering and development of URS, FRS and SDS for validating Tracelink and Optel serialization software systems; and utilizing 21 CFR Part 11, GMP, ICH guidelines and GAMP requirements. Must have basic knowledge of xml and EPCIS file formats. 5% domestic travel required. Apply at https://careers.regeneron.com, reference code R4619.
