CSV Specialist

Description/Comment: - DURATION - THRU OCT 2024 - REMOTE WITH TRAVEL - SHIFT - PRIMARY MON-FRI 8AM - 5PM EST. HOURS MAY SHIFT TO 2AM - 11AM EST BASED ON BUSINESS NEEDS. 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 & weekendsIII. Position Requirements:Education or Equivalent:Bachelor of Science in an Engineering, Computer Systems or Science FieldKnowledge/Skills Requirements:3-5 years experience as a CSV specialist within the Life Sciences Industry1-2 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: