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Computer Systems Validation Specialist

Company: Thermo Fisher Scientific
Location: Chapel Hill
Posted on: February 14, 2019

Job Description:

Thorough understanding of industry standards and best practices for computer system validation such as Good Automated Manufacturing Practice (GAMP 5) and American Society of Testing Materials (ASTM E2500). In addition, knowledge of current Good Manufacturing Practices (cGMP) regulations and Code of Federal Regulations 21 CFR Part 11 and EU Annex 11Work closely with internal and external teams to provide the necessary design, configuration, deployment, and support during the implementation of the client's computer system. Validation documentation creation and development including GxP (GxP is a general term for good practice quality guidelines and regulations).Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Preventative Qualification Protocols, Reports, and Standard Operating Procedures. Managing Vendor Installations and Vendor Validation Documentation. Test Execution and Deviation Management. Planning and scheduling of validation and Validation Lifecycle deliverables.Education:Bachelor---s Degree in engineering or biological sciences or related field.Experience: 5 years experience in a regulated industry or 2-3 years with related technical knowledge including data integrity related to quality control data from chromatographic systems. Experience with laboratory metrology and instrumentation compliance. Project Management and/or prior management experience preferred. Experience with SAP, EDMS, Trackwise, or Empower. Candidates should have strong Biotechnology and Pharmaceutical process understanding. Candidate must have strong communication and organizational skills. Understanding of the Validation Lifecycle (GAMP 5) Understanding of GxP, GAMP, CFR---s as they relate to validation Understanding of applying standard operating procedures (SOP---s), work instructions, and regulatory requirements for validation of computerized systems.

Keywords: Thermo Fisher Scientific, Chapel Hill , Computer Systems Validation Specialist, IT / Software / Systems , Chapel Hill, North Carolina

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