Validation Engineer

Qualification:Bachelor’s Degree in Computer Science, Computer Information Systems, or software engineering, with equivalent relevant experience

Interview Type:1
Job Description:
·         Conduct various reviews, risk analyses activities with primary focus on review and approval of validation test scripts and incident reports.

·         Participate in change control activities as part of enhancements, defect fixes, data migration activities.

·         Provide guidance to change leads to ensure compliance with established procedures as well as assist teams in creating recommended SDLC deliverables.

·         Apply a risk-based approach and prioritize validation activities in line with the project schedule.

·         Implementation of GxP (GMP, GDP, GLP, GCP) requirements into the systems.

·         Review and approve validation test protocols for enterprise applications and quality systems. Perform periodic reviews on regulated/quality critical systems.

·         Coordinate with cross functional teams from different projects to complete validation deliverables on time.

·         Assist system retirement/decommissioning activities as needed, with primary focus on data migration and data archival from legacy systems, ensure data has been completely migrated/archived into replacement system.

Job Required Skills:
Regulatory Assessment, Validation Plan, Data Migration Plan, User Requirement Specifications, Functional Requirement Specifications, Test Scripts, Testing Summary Report, Deviation Log, Production Support Plan, Validation Summary Report, Data Migration Summary Report, HPQC, HP ALM, JIRA, i-browse, Microsoft VSTS, TrackWise, SAP, Salesforce.com, HP ALM, DocuSign, ServiceNow, Sharepoint, Office 365, Workday, Concur, Coupa, JDE, Service Max, QAD, Windchill, Veeva, Documentum, Medidata RCM, LIMS