Role: Global Computer Validation Specialist Location: Marlborough, MA Duties: • Hands on position responsible for validation of GAMP 5 Category 4 (configurable off the shelf) computer systems in a GxP environment. • Authors all validation deliverables including risk assessments, validation plans, user requirements, test plans, test scripts, traceability matrix, test summary reports, and validation summary reports. • Reviews executed test scripts. Provides input to the project manager for all validation activities and deliverables. • Reviews vendor provided documentation for suitability. • Participates in project team meetings with IT and Business. • Requires participation in early morning and/or evening teleconferences with global project teams. Skills: • Successful candidates will have strong validation experience including the validation of global data repositories (warehouse / data lake) with analytics and collaboration tools in a GxP environment • Have a good understanding of IT infrastructure terminology and concepts and a thorough understanding of electronic records and electronic signatures requirements (FDA, PIC/S, Annex 11). • Must have excellent oral and written communication skills. • Must be able to manage multiple validation projects at one time. • Experience validating systems used to support clinical trials in a pharmaceutical environment (e.g. eTMF, CTMS, safety systems, clinical trial registration, statistical analysis, EDC) and GMP/QMS activities (e.g. labeling artwork management, serialization, document management, learning management) preferred. • Must have a minimum of 2 to 3 years' experience writing CSV test scripts, protocols and summary reports • Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.
