Job Description :
Title: Validation Lead or Manager with Oracle EBS or SAP
Location: San Francisco
Duration: Long term

Biogensys is hiring senior Validation Lead/Manager with 9 -12 years of experience for contract to hire position. Pharma with EBS patching experience is required.

21 CFR Part 210 / 211
GAMP 5 Risk Based validation / ICH Q9 hands on implementation knowledge
Manufacturing, Distribution process and procedure
Experience in managing large implementations / upgrade project
Strong knowledge on change management procedure & process; Should have handled more than 20+ change requests
Hands on knowledge on Deviation and CAPA Management
Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
Must possess formal training/certification on Testing & Validation
Excellent communication skills
Excellent technical writing skills
Should be able to work independently with minimum supervision
Should have worked in cross-functional environments and comfortable to liaison with business

Application skills: Minimum 3 items, mainly PTM and OTC
Hands on testing experience in Oracle EBS Plan to Make (PTM) module
Inventory Control, Inventory Tracking
Production Control, Production Execution
Quality Management
- Hands on testing experience in Oracle EBS Order To Cash (OTC) module
Pick and Pack Order
Ship Order
Managed Recall
Return Goods Management
- Hands on testing experience in Oracle EBS to MES system, 3PL
Supplier Management
- Hands on testing experience in Oracle Fusion Middleware
Requester, Provider and Median services for GxP interfaces
Backup and Restore is plus
Disaster Recovery is plus