Software Validation Project Manager

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POST DATE 8/27/2016
END DATE 10/23/2016

Regeneron Pharmaceuticals, Inc. Rensselaer, NY

Company
Regeneron Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360402
AJE Ref #
575993139
Location
Rensselaer, NY
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p 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. br / br / Summary: This position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a compliant validation process for quality information technology systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards. br / br / Essential Duties and Responsibilities include, but are not limited to, the following: br / * Analyzes the results of testing and determines the acceptability of results against predetermined criteria. br / * Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. br / * Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation. br / * Coordinates with other departments or outside contractors/vendors to complete validation tasks. br / * Participates in regulatory audits and communicates companies computer validation policies. br / * Assesses companies computer systems and identifies any potential Part 11 or Annex 11 gaps. br / * Manages projects and prepares status reports. br / * May supervise, lead, or manage lower-level personnel. br / * Trains /advises less experienced Specialists and Technicians. /p p