Job Description
Title: Computer System Validation Specialist (OVERNIGHT) Positions: 1 Start: May 29 thru Oct 28 2023 Location: REMOTE Hours: Sunday through Thursday, 9:30PM - 6:30AM EST. Special Notes: MUST BE FLEXIBLE to work night and weekends Education: Bachelor of Science in an Engineering, Computer Systems or Science Field Knowledge Requirements: - 3-5 years experience as a CSV specialist within the Life Sciences Industry - 1-2 years experience with ERP validation, SAP S/4 HANA experience preferred - Knowledgeable in US and Global Computer system Validation requirements - Knowledge of GAMP 5 methodology - Experience with ValGenesis, preferred Responsibilities: - Hands-on CSV specialist on assigned projects, responsible for the creation, execution and coordination of the project’s CSV deliverables - CSV advisory for the planned projects - Training of testers and approvers of CSV processes and systems - Perform Protocol Exception Assessments and Resolutions - Provide support to testers, as needed, with validation questions
Title: Computer System Validation Specialist (OVERNIGHT)
Positions: 1
Start: May 29 thru Oct 28 2023
Location: REMOTE
Hours: Sunday through Thursday, 9:30PM - 6:30AM EST.
Special Notes:
MUST BE FLEXIBLE to work night and weekends
Education:
Bachelor of Science in an Engineering, Computer Systems or Science Field Knowledge
Requirements:
- 3-5 years experience as a CSV specialist within the Life Sciences Industry
- 1-2 years experience with ERP validation, SAP S/4 HANA experience preferred
- Knowledgeable in US and Global Computer system Validation requirements
- Knowledge of GAMP 5 methodology
- Experience with ValGenesis, preferred
Responsibilities:
- Hands-on CSV specialist on assigned projects, responsible for the creation, execution and coordination of the project’s CSV deliverables
- CSV advisory for the planned projects
- Training of testers and approvers of CSV processes and systems
- Perform Protocol Exception Assessments and Resolutions
- Provide support to testers, as needed, with validation questions