SAP Validation Manager

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

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.

#LI-NP

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.