Sr. CSV Engineer, Trackwise
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
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