Validation Specialist

Title for this position: Validation SpecialistOnsite: yes, remote to startDuration: 6+ months This position is located in Princeton, NJ Job Description: 6+ years experienceApply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processesFollow SOPs and industry best practicesPossess 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 systemReview validation deliverables for projects which are contracted to third party suppliersMaintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issuesAssist in planning, implementing, and documenting user acceptance testing" Review computerized systems validation documents such as:" Requirements Specification" Design Specification" CSV Risk Assessment" Test Plans" Test Summary Reports" Data Migration Plan" Pre/Post Executed Test Scripts" Traceability Matrix" Release to Production StatementsDirect and review testingProvide guidance on quality issues that affect the integrity of the data or the systemObtain and respond to QA reviewParticipate in establishing standard quality and validation practicesIndependently assess compliance practices and recommend corrective actionsApprove validated computer system related change requestsMonitor regulatory and inspection trends and advise the business on suitable actionAbility 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.Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client 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 structureThe Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.