for Enterprise System Partners Ltd

CSV Engineer

Enterprise System Partners Ltd
Cork
We are currently recruiting for a CSV Engineer required to work on validation activities for Pharma / Biopharma projects. Responsibilities Partner with our project teams in performing Information Systems CSV across a range of projects. Development and execution of the qualification of Information Technologies Development of life cycle documents necessary to address the validation lifecycle Preparation / testing of validation protocols, and all associated documentation for equipment and systems Review and approval of all Computer Systems / Software Validation Documentation Requirements BS or MS in Engineering, Computer Science or IT is preferred Minimum of 3-5 years' experience in a pharmaceutical, biotech or medical device environment Experience with the management, development and/or validation of Information Systems Technology projects - MES, LIMS, Trackwise etc Prior experience in working with cGMPs and/or GLPs and Quality Systems Knowledge of FDA and GMP guidelines a must About Enterprise System Partners LtdEnterprise System Partners (ESP) provides full project life cycle support & consultancy globally for integrated manufacturing IT solutions for biotechnology, pharmaceutical and medical device production, specializing in MES and Serialization.
2017-03-02 / full time
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