Validation Engineer 2

CSV SpecialistLocation: Portsmouth, NH, 03801 Duration: 06 MonthsThe CSV Specialist Level 3 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 3 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members.AccountabilitiesSpecialist will be involved as the QA CSV representative during small and large-scale projectsPerform all aspects of QMS process' – Change Control, Deviations, CAPAsExecute all responsibilities as CSV project lead for simple projectsOversee/perform all CSV qualification activities for DeltaV and Syncade systemsPerform Validation Maintenance of computerized systemsReview/Revise CSV SOPsPerform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)Assist with audits and inspectionsPerform other duties as assignedEducationBachelor's Degree required Field of Study: Computer Science / Software Engineering (Preferred)Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems ValidationStrong written and oral communication skillsStrong organizational and time management skills