Validation Lead

Description

Purpose of the Position 1. Act as Infrastructure Validation Lead for Data Center Project. The Data Center Project encompasses multiple platforms, servers and systems, as well as applications residing on those servers. Critical Job Responsibilities 1. Develop qualification strategy for the Data Center Project. 2. Generate master validation plan, qualification plan, protocols, risk assessments, trace matrixes, test plans, reports required for the facets of the Data Center Project, as needed. May generate Design Specifications and /or System Specifications. 3. Gain understanding and follow defined SDLC process for validation/qualification. Ensure qualification processes are executed as defined by procedures. 4. Communicate status, solutions and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project. 5. Manage qualification testing, generate test scripts, as needed. Execute testing as required. May coordinate team of testers . 6. Collaborate with business, quality, and technical individuals throughout project in generation of project / qualification required deliverables 7. Manage electronic routing of required documentationensuring compliance to current procedure for eapproval. 10. Prepare validation package(s) for archival. Required Qualifications 1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business. 2. Highly skilled in Computerized System testing and validation in the healthcare industry. At least 710 years validation experience in infrastructure qualification. Application validation experience a plus. 3. Proven results in managing validation aspect of software / infrastructure project implementation. 4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211, 820, PIC/s), as well as SarbanesOxley, HIPAA, and privacy regulations. 5. Experience with use/control of Electronic Records/Electronic Signatures and electronic submissions to regulatory agencies. 6. Strong technical backgroundexperience with Virtual Environments, UNIX/Wintel, iSeries, Oracle, Sharepoint, VMWare, etc. 7. Experience working in a highly regulated environment; GxP, QSR framework preferred. 8. Solid project organizational skills. Ability to multitask. Must have strong analytical problem solving skills. 9. Excellent communication including written, verbal, and listening skills. 10. Selfmotivated, detail oriented, takes initiative and ability to work independently without close supervision.