Validation Engineer

Job Title: Validation EngineerLocation: New Brunswick, NJ (08903)(Candidates should be 50% onsite at either New Brunswick or Lawrenceville)Duration: 6 Months(There is a chance this will be extended past 6 months if funding is approved.)Must Have List5+ years of HP ALM5+ years of 21 CFR Part 11 experience5+ years of CSV with Biopharma spaceHighly PreferredRecent Client experience.LIMS implementation.Responsibilities6+ years' experienceApply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes.Follow SOPs and industry best practices.Possess expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.Facilitate the Computer System Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.Review validation deliverables for projects which are contracted to third-party suppliers.Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.Assist in planning, implementing, and documenting user acceptance testing.Review Computerized Systems Validation DocumentsRequirements SpecificationDesign SpecificationCSV Risk AssessmentTest PlansTest Summary ReportsData Migration PlanPrePost Executed Test ScriptsTraceability MatrixRelease to Production StatementsAdditional ResponsibilitiesDirect and review testing.Provide guidance on quality issues that affect the integrity of the data or the system.Obtain and respond to QA review.Participate in establishing standard quality and validation dependently assess compliance practices and recommend corrective actions.Approve validated computer system related change requests.Monitor regulatory and inspection trends and advise the business on suitable action.Ability to create documents to an existing document standard.Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.Required Skills and KnowledgeAdvanced knowledge of complete MS Office suite and Visio.Firm understanding of technology platforms as needed for the project.Experience with electronic document management systems (e.g., Documentum, Qumas, SharePoint, etc.); application development and lifecycle management (e.g., HP ALM, JIRA, etc.); and IT service management systems (e.g., ServiceNow, SAP Solution Manager, etc.).Excellent oral and written communication skills in English.Strong expertise and ability to interview and accurately interpret communication requirements of team members.Once trained, have the ability to work independently on CSV projects with minimal oversight.Ability to perform in a highly matrixed organization structure.

Created: 2025-02-22