Validation SME IT CSV for SAP Application Foster City, CA Hybrid

Job Title: Validation SME   IT CSV for SAP Application
Location: Foster City, CA   Hybrid (3 days onsite mandatory)
Duration: 12 months plus extension potential
Experience: 10+ years
Industry: Life Sciences / Pharmaceutical
 
Please send your updated resume to  
Job Description:
We are looking for a Validation SME with strong experience in SAP ECC/SAP S/4HANA validation and Computerized System Validation (CSV) to support a large SAP S/4HANA transformation program. 
Mandatory Skills:

• 10+ years of IT experience, preferably 12+ years in Life Sciences/Pharma

• Strong SAP ECC / SAP S/4HANA validation experience

• Hands-on Computerized System Validation (CSV) experience

• Strong knowledge of GxP, 21 CFR Part 11 and GAMP 5

• Experience developing/reviewing/approving validation deliverables

• Experience with validation strategy, SDLC and risk-based testing

• Knowledge of Quality & Regulatory Compliance

• Understanding of Data Integrity, Data Privacy, Information Security and SOX IT

• Knowledge of SAP implementation tools such as Solution Manager, CHARM, SAP GRC, DRC, MDG and RISE

• Understanding of SAP data migration tools such as SNP/ADM

• Experience working with Lean/Agile validation approaches

• Strong communication, presentation and stakeholder management skills