What are the responsibilities and job description for the SAP Validation Manager position at Legend Biotech US?
Legend Biotech is seeking SAP Validation Manager as part of the IT team based in Somerset, NJ.
Role Overview
The SAP Validation Manager will be a member of my team responsible for maintaining and executing all aspects of Computer System Validation deliverables and activities related to SAP S4/HANA application enhancement releases and change control implementation.
Key Responsibilities
- Lead and/or participate in Operational Computer System Validation support of Legend’s SAP S/4 HANA Computerized ERP Systems.
- Lead or participate in the routine CSV activities required to maintain compliance of SAP S/4 HANA, including but not limited to:
- Scheduled/Routine enhancement releases
- Change Management process (GxP and non-GxP Change controls)
- Deviation Management
- Periodic System Review
- In support of the above for SAP S/4 HANA:
- Develop, author, and assist business in production of requirements, test scripts, reports, and other validation lifecycle documentation
- Execute and assist the business in the execution of validation testing utilizing an automated validation lifecycle system
- Own, review, approve, and maintain validation documentation and deliverables utilizing the automated validation lifecycle management system in an inspection-ready state
- Contribute to the reviewing, editing, and authoring of procedural documents (Policies, SOPs, Work Instructions, Templates) related to the CSV process.
Requirements
- Bachelor’s degree in a Life Science, Information Technology, or a related field.
- 8-10 years of hands-on experience in Computer System Validation (CSV) within the biotech or pharmaceutical industries.
- 3-5 years of experience with the implementation and support phases and validation requirements for ERP systems in a GxP environment, particularly as applied to Cell Therapy or Biologics.
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