Validation Engineer

1 week ago


Singapore SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Job Responsibilities:

  • MVP Matrix Update
  • Software Assessment
  • Spreadsheet Assessment
  • Software Validation Package:
  1. MVP ( Individual Software Master Validation Plan )
  2. SRS
  3. 21 CFR Part 11 Assessment
  4. FMEA
  5. IQ / OQ / PQ Protocol
  6. IQ / OQ / PQ Report
  • Procedure / Form Update
  • New Software Development
  • Plant Improvement Projects
  • FDA Preparation for Software Validation
  • Technical Advice for Overall Validation
  • Review of Existing Software
  • FUE Validation Package:
  1. MVP ( Individual Master Validation Plan )
  2. URS
  • FDA Preparation for FUE Validation
  • Technical Advice for Overall Validation

Job Requirements:

  • Minimum Degree in Engineering
  • Minimum 2 years experience with innovative and creative mindset.
  • Project Management and Leadership abilities
  • Team Leader and Quality Advocate
  • Technical Writing Skills
  • Analytical and Logical in relation to Validation activities
Tell employers what skills you have

FDA
FMEA
Risk Assessment
Technical Writing
GMP
Project Management
Team Leader
Regulatory Requirements
Manufacturing
Writing Skills
Commissioning
Software Development
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