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Validation Specialist

Company: Career Developers, Inc.
Location: Princeton
Posted on: February 26, 2021

Job Description:

Validation Specialist (6+ Month Assignment)Location: Princeton, NJ (Remote for now but must be local to come to the office once the policy is lifted)Rate: OPENStart Date: January 18th, 2020Must Haves:* 6+ Years of CSV experience in the biopharmaceutical industry* 4+ Years of GAMP / 21 CFR Part 11 experience* 4+ years of Client ALM* 2+ years of experience in Change Control* 2+ years of experience in Digital IntegrityExperience:* 6+ years' experience* Apply 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, 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 testingReview 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 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 practices* Independently assess compliance practices and recommend corrective actions* Approve validated computer system related change requests* Monitor regulatory and inspection trends and advise the business on the 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.* Advanced 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. 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 structure

Keywords: Career Developers, Inc., Trenton , Validation Specialist, Other , Princeton, New Jersey

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