Infotech Spectrum, Inc. has openings for Validation Engineer in Santa Clara, CA:
Job Title: Validation Engineer
Job duration: 40 Hours / Week, Permanent position, Full time
Job Duties: Understanding and adhering to the Client Regulations/Processes, SOPs on Project Management, Change Management, Document Management and Quality Management and
Computerized System Validation concept with regards to document management and Model Methodology. Supporting stakeholders throughout the project delivery with regards to aspects
of project related risk, Validation deliverables, compliance and quality. Performing the Validation activities for regulated applications/systems across multiple computing environments. Routing the validation protocols for business review and approval. Leading the planning for all validation testing activities, design IQ, OQ, PQ and Pre-validation UAT protocols for new or existing system to produce products/software meeting internal and external specifications, safety, and quality requirements. Developing Validation Plan to define the validation scope, strategy and approach to be compliant. Understanding study product characteristics or customer requirements and confer with management to determine validation objectives, scope, approach and standards. Analyzing validation test data to determine whether systems or processes have met validation criteria/requirement specifications. Performing dry run to test critical functions and validating the approved protocols in controlled environment and reporting deviations and identifying root causes of production problems. Developing defect reports and tracking them for its resolution and maintenance Requirements Traceability Matrix (RTM) and Prepare Test Summary Report to summarize all the test activities. Track and monitoring review and approval of validation deliverables, participate in meetings with project team and Client Stakeholders as required. Participating in project planning, project meeting, estimation and risk assessment. Ensuring adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests. Coordinating the implementation or scheduling of validation testing with affected departments and personnel. Creating, populating or maintaining databases for tracking validation activities, test results, or validated systems.
Job Requirements: Required Master’s or foreign equivalent in Computer Science, Information Systems, Computer Information Systems, MIS, Engineering (Any), or any related field + 1 year of experience in the job offered, QA Engineer, Reliability Engineer, IT Analyst, or related. Must be able to travel/relocate to various client sites throughout the U.S.
Number of Openings: 3
Salary: $122,408.00/Year to $127,000.00/Year
Location of work: Infotech Spectrum, Inc.
2060 Walsh Avenue, Suite # 120
Santa Clara, CA 95050
To apply please send resumes to HR, Infotech Spectrum, Inc., 2060 Walsh Avenue, Suite 120, Santa Clara, CA 95050 or email resumes to firstname.lastname@example.org