Sr. CSV Engineer, Trackwise - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
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:
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
- 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
Source : Katalyst Healthcares & Life Sciences
