Design, author and execute validation deliverables according to US FDA, EU Annex 11 & GAMP 5 guidelines for IT Information Systems & general understanding of technical design and architecture IT landscape.Provide support as Validation & Compliance Lead to managed service project and other ongoing projects of the IT Applications.Responsible for ensuring the accuracy, completeness, and compliance of validation deliverables by reviewing the validation packages. This includes providing oversight and assurance that validation deliverables meet FDA regulatory, cGMP/GMP, and internal quality requirements.Design of Data migration & testing methodology for successful migration of data from source applications to the new data model to ensure the data compliance.To ensure the appropriate Project planning, scheduling and tracking quality of service delivery through effective development of systems, processes, and training of resources.Responsible for creating Verification plans, test method development to complaint with FDA and ISO standards (CFR Part 820, ISO 14971, ISO 13485, ISO 10993, ISO 9001 and IEC 62304).Position requirements: Bachelor’s degree or a foreign equivalent degree in Biotechnology, Pharmacy, Bioengineering, Bio Medical Engineering, Chemical Engineering, Computer Science Engineering, Engineering (any) or related field plus five years of progressive work experience in any position/title providing experience with Oracle Clinical.Qualifying experience must include experience with Oracle Clinical.Position requires travel/relocation to various unanticipated client locations throughout the U.S. with expenses paid by the employer.