CSV Specialist
Abacus Service Corporation
•$80K — $110K *
Somerset, NJ 08873 In-Person
1 month ago
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Job Description
Description/Comment: - DURATION - THRU OCT 2024 - REMOTE - SHIFT - SUNDAY - THURS 9:30PM - 6:30AM EST. MUST BE FLEXIBLE TO WORK NIGHTS AND WEEKENDS.
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. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 113 14 Schoolhouse Road 13-4268760 Somerset NJ 08873 United States Education: dditional Job Details:
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. Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 113 14 Schoolhouse Road 13-4268760 Somerset NJ 08873 United States Education: dditional Job Details: