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Job Title: CSV Specialist
Location: 113 14 Schoolhouse Road 13-4268760 Somerset NJ 08873 United States
Duration: 12+ months.
REMOTE - SHIFT - SUNDAY - THURS 9:30PM - 6:30AM EST. MUST BE FLEXIBLE TO WORK NIGHTS AND WEEKENDS.
Description:
II. Specific Duties, Activities, and Responsibilities:
Other responsibilities will include:
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.
At all times, exemplify the highest level of business and personal integrity
Must be able to work nights & weekends
III. Position Requirements:
Education or Equivalent:
Bachelor of Science in an Engineering, Computer Systems or Science Field
Knowledge/Skills 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
Detail-oriented with ability to accomplish objectives.
Demonstrated ability to work independently.
Intellectt INC
