Sr. Computer Systems Validation Engineer

Under limited supervision, design and plan protocols for processes to produce complex computer systems meeting quality requirements; develop and review user requirement specifications, functional requirement specifications and design specifications to determine validation objectives and standards; develop validation plans, process flow diagrams and test cases; perform gap and risk analysis and develop remediation plans; coordinate validation activities; develop test procedures, test requirements, test standards test plans and test cases; analyze, create, pre and post review validation test data and documentation to determine whether systems or processes have met validation criteria; identify root cause of problems; coordinate scheduling of validation testing and conduct validation testing of software and systems; review and approve change tickets during change control process; provide detailed reports based on results of validation testing; assist in training staff on validation protocols and system SOPs; mentor less experienced team members; and use Windows, MHRA, LVLIMS, LabwareLIMS, TrackWise, IQ, OQ, GAMP, cGMP, GDP, GLP, RTM, HP ALM, Quality Center and related tools.

Minimum Qualifications Education :

Master degree in Computer Engineering, Network and Communications Management, Information Systems, or in a related field of study (will accept equivalent foreign degree);

Experience  : Two (2) years of experience as a Systems Engineer, Network/Systems Administrator, Network Architect, or in a related occupation;

Other Requirements:

Experience must include two (2) years of work with MHRA, LVLIMS, LabwareLIMS, GAMP and cGMP; must be willing to relocate