WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.
Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.
Our parent company, WuXi AppTec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally WuXi AppTec spans to more than 39,000 employees with 32 facilities in 9 countries.
Provides in process analysis, process and system design, systems development, configuration, testing, implementation, and training to support the ERP functions of our business stakeholders according to specification and schedules while meeting quality requirements. This role also is adept at building cross-functional relationships while working with a high degree of autonomy and can assist IT Management with the guidance of the team where necessary.
- Provides technical support and analysis directly within SAP B1 (MRP/WMS), and related integration knowledge between SAP B1 and STARLIMS, Microsoft Dynamics GP and CRM.
- Works in partnership with stakeholders to improve business processes impacted by technology changes.
- Performs enterprise analysis by planning and scoping several inter-related initiatives and helping senior-level business stakeholders make informed decisions about which initiatives to execute and how to execute.
- Lead and facilitate teams of cross-functional subject matter experts.
- Build strong and positive working relationships with all functional areas across the company and understand their needs.
- Use techniques such as focus groups and requirements workshops to elicit, analyze, and document clear and concise user requirements/stories.
- Use visual modeling techniques such as work-flow diagrams or wireframe prototypes to identify gaps between business requirements and existing technology solutions.
- Facilitates testing execution and develops test evidence.
- Manage requirements changes and ensure appropriate stakeholders are involved in all decisions about change.
- Train end users to ensure they understand all process and procedural changes.
- Collaborate with training staff to create appropriate training materials and deliver the training.
- Post-implementation, evaluate progress made against the business objectives for a project to show the extent to which they were fulfilled.
- Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance.
- Provide Quality oversight, review, and approve Validation.
- Manage the full lifecycle of system validation projects; ensure the delivery of quality validation deliverables throughout the lifecycle of the SAP program.
- Develop and manage GxP system lifecycle documentation, including Validation Master Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrices, Validation Reports, SOPs, Change Control Documentation, and Risk Assessment reports
**** May be required to work Holidays and weekends****
8+ years of relevant experience or equivalent
• Bachelors’ degree or equivalent experience
Knowledge / Skills / Abilities:
• ERP (SAP ECC or SAP B1) Implementation experience
• Hand On SAP Functional analysis and configuration experience
• Functional testing , User Acceptance testing and Validation work in SAP System
• Integration SAP system to different ERP (Non SAP) Systems
• SAP system cutover activities
• SAP testing experience – Functional Unit test, Integration test, UAT (User
Acceptance Test)
• Waterfall or Agile business analysis experience
• Lean six sigma experience preferred
• Leadership and facilitation skills
• Detail-oriented with expertise in problem solving, analytical and critical thinking
skills
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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