CSV Engineer Role
CSV Engineer Role
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment ensuring data integrity and compliance. This includes writing reviewing and executing validation documents in alignment with regulatory expectations.
Responsibilities:
- Validate GxP computerized systems/analytical instruments such as liquid handlers Cellaca MX and robotic arms.
- Lead development and execution of Data Integrity documentation including DI Specifications User Access Test Scripts Data Flow / Audit Trail Risk Assessments Grouped and Individual DI Test Scripts.
- Participate in configuration reviews and verify implementation of system security access roles and audit logging.
- Coordinate closely with automation and validation engineering teams to ensure readiness of computerized systems for testing.
- Bachelors Degree or equivalent required.
- 5-10 years of industry experience.
- Strong understanding of GxP requirements and 21 CFR Part 11 compliance.
- Demonstrated experience drafting and executing DI testing across similar instruments as seen in complex lab environments.
- Familiarity with validation lifecycle documentation and electronic protocol management systems.
- Experience with highly automated systems that are integrated into systems such as Delta V or Syncade.
Employment Type
Full Time
