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Sr. CSV Engineer, Trackwise

3 months ago

Seattle, United States I.T. Solutions, Inc. Full time

Role: Sr. CSV Engineer, Trackwise

Location: Seattle Washington(Onsite)

Type: Contract

Length: 1 year at least


Description: Seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.


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