Infotech Spectrum, Inc. has openings in Santa Clara, CA:
Job Title: Validation Engineer
• Develop Validation Plan to define the validation strategy to be compliant with FDA regulations and Client company policies.
• Apply Process Validation, Regulatory requirements and Drug development process knowledge and experience to analyze the requirements.
• 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 that supports manufacturing in the plant.
• 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 to meet company policies and procedures.
• Execute validation test protocols and document the test results.
• Develop defect reports, and track them for its resolution and maintain Requirements Traceability Matrix (RTM) and Prepare Test Summary Report to summarize all the test 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.
• Prepare User Requirements, System Requirements including system flow diagram Specifications, Configuration and Design Specifications.
• Participate in internal or external training programs to maintain knowledge of validation principles.
• Use HP Quality Center for tracking validation activities, test results and test defects
JOB REQUIRMENT: Required Bachelors or foreign equivalent in CS, CA, CIS, IT, MIS, Engineering (Any), or any related field. Must be able to travel/relocate to various client sites throughout the U.S.
Location of work : Infotech Spectrum, Inc.
2060 Walsh Avenue, Suite # 130, Santa Clara, CA 95050