END DATE October 15, 2016

Engineering and Automation Technical Writer

Regeneron Pharmaceuticals, Inc. - Rensselaer, NY

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Job Description

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. /p p Summary: Authoring, editing, reviewing, evaluating Engineering and Automation GMP documentation, procedures, assessment, etc. for analytical laboratory instrumentation, manufacturing equipment, automated process control systems and enterprise systems. Lead other department writers in coordination and completion of group assignments. /p p Essential Duties and Responsibilities include, but are not limited to, the following: br / * Develop, author and maintain technical writing standards for the Automation and Engineering unit. Such as document authorship aids, checklists and templates. br / * Write and create automation periodic evaluation reports for automated systems used in commercial manufacturing, analytical testing and training/document tracking/retention. br / * Perform and document investigations and risk assessments of engineering and automation related deviations and anomalies utilizing quality/risk management tools. br / * Write and manage review/approvals for modifications/change controls/revision histories to documents (standard operating procedures, work instructions, job aids, etc.). br / * Author and review test plans/test cases/matrices/scripts/technical evaluations and IOQ documents to support validation activities. br / * Author, edit, review, evaluate and maintain system design documentation (such as User Requirement Specifications, Functional Specifications, Software Design Specification, etc.), following GAMP 5 guidance. br / * Author, edit, review, evaluate and maintain department cGMP documentation: standard operating procedures, procedural quizzes, work instructions, standard engineering specifications, job aids, FMEA, gap analysis, memos/addendums/amendments, on-the-job training documentation, instructor-led training material, forms/templates/manuals, equipment/system genealogy/lineage documentation, etc. br / * Coordinates projects and assignments of other department technical writers. /p p