Infotech Spectrum, Inc. has openings in Santa Clara, CA:
Job Title: Validation Engineer
Job Duties: Develop Validation Plan to define the validation strategy to be compliant with FDA regulations. Apply Process Validation, Regulatory requirements and experience for performing requirement risk analysis. Perform the IT Validation activities for FDA regulated applications/ systems across multiple computing environments. Understand the Client Validation Procedures and Requirements in validating new or modified processes, systems. Lead the planning for all validation testing activities (OQ, PQ and Pre-validation UAT protocols). Develop Test Strategy and Plan in execution of Operational and Performance protocols. Execute validation test protocols and document the test results. Develop defect reports and track them through triaging for their resolution and maintain Requirements Traceability Matrix (RTM) and Prepare Test Summary Report to summarize all the validation activities including any open deviations. Track and monitor review and approval of validation deliverables, participate in meetings with project team and Client Stakeholders as required. Develop User Requirements, Functional Requirements including system flow diagram Specifications, Configuration and Design Specifications. Participate in internal or external training programs to maintain knowledge of validation principles.
Job Requirements: Required Masters or foreign equivalent in CS, Technology, CIS, MIS, Engineering (Any), or any related field. Requires 1 year of experience in the job offered, Validation Engineer, Software Engineer, Consultant, Programmer Analyst, Testing Analyst, or related. Must be able to travel/relocate to various client sites throughout the U.S.
Location of work: Santa Clara, CA.
To apply please send resumes to HR, Infotech Spectrum, Inc., 2060 Walsh Avenue, Suite 130, Santa Clara, CA 95050 or email resumes to firstname.lastname@example.org