Senior Validation Engineer (SAP)
Published | September 13, 2023 |
Location | Cambridge, MA |
Category | Default |
Job Type | Full-time |
Description
A pharmaceutical company in Massachusetts has a great Remote opportunity awaiting a new Validation Engineer (SAP). In this role, the Validation Engineer (SAP) will will be responsible for assisting with the implementation of SAP S/4HANA as well as helping to drive and execute all validation efforts.
Responsibilities:
The Validation Engineer (SAP) will:
- Help define the overall validation approach for a large SAP S/4HANA transformation project
- Author key validation documents: Validation Plans, Validation Summary reports, Test Plans, etc.
- Advise project and technology teams on validation and data integrity best practices and approaches
- Collaborate with QA on process definition and improvement, author and revise CSV related SOPs
- Coordinate CSV activities (UAT, document reviews) for the SAP implementation.
- Oversee CSV readiness for inspections and audits, support SAP business teams during inspection activities
- Perform other duties, as needed
Qualifications:
- 8+ years of Computerized System Validation experience with a primary focus on SAP
- Bachelor's Degree in Biotechnology Engineering and/or Computer Science
- Proven experience in leading sustainable and nimble validation efforts for SAP implementations
- Demonstrable experience in authoring key validation deliverables such as validation plans, validation reports and validation strategy approaches
- Experience in the Life Sciences industry
- Experience working with Kneat or other validation management systems
- Solid problem solving and time management skills
- Great interpersonal skills
- Excellent communication skills (written and verbal)
- Strong attention to detail
- Highly organized