CSV Engineer

2 months ago

Seattle, United States Fusion Life Solutions Full time

Role: Sr. CSV Engineer,
Location: Seattle, Washington
Type: Contract
Length: 1 year at least

As a Computer Systems Validation (CSV) Consultant you will:

  • Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical and biotech Manufacuring and other GxP and GAMP regulated environments
  • Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications
  • Engage in value-add relationships to deliver outstanding project outcomes and identifying new more optimal opportunities for processes and procedures
  • Share best practices, industry knowledge, and personal expertise to educate client in formal and ad hoc settings



Requirements:

  • Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
  • Experience with Trackwise Digital (Cloud based solution)
  • Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management considering computer software assurance (CSA) principles
  • Professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in GxP and GAMP regulated environments
  • Strong experience with GAMP and ability to share and execute new GAMP protocols
  • Experience with Data Integrity impacts on Validations including Audit Trail Risk Assessment
  • Flexibility and adaptability - work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked
  • Bachelor's or 4-year degree from an accredited college or university

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