Position : Validation Engineer
Location : Plano, TX
Education Bachelor’s degree in Mechanical Engineering, or a closely related engineering discipline and some experience in an engineering field.
Job Responsibilities: :
- Work on preparation of work instruction, standard operating procedure and qualification documents for cleaning validation.
- Develop Verification/Qualification deliverables including but not limited to Work Instructions, Bill of Materials (BOM), Routers, Functional and Design Specifications, Test Protocols (IQ, OQ, PQ), Validation Deviations and Summary Reports.
- Perform Process Capability analyses, Gage R&R studies and identify process variations and trends using Minitab.
- Execute Test Method Validation plan and document the reports.
- Lead and execute project goals while working with cross functional team.
- Perform and review risk assessment using Gap Analysis.
- Lead process validation activities to timely meet the deadlines by working with cross functional team.
- Work closely with department’s management team to identify improvement opportunities.• provide recommendations around the business process changes as well as advise business on options, risks, and costs.
Email id and address to contact: email@example.com, 1605 S Main St, Suite#112, Milpitas, CA-95035. Call: 510-771-9226