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Validation Engineer
Ref No.: 18-00253
Location: Foster City, California
Position Type:Contract
Title: Validation Engineer
Location: Foster City, CA
Type: Contract

Responsibilities:
  • Authoring Change Controls
  • Authoring and executing test protocols
  • Documenting and investigating issues through Discrepancy or Issue Reports
  • Authoring validation work stream deliverables, including, but not limited to:
o Design Specifications
o Report Specifications
o User and Configuration Specifications
o Installation Qualification Protocols
o Operation Qualification Protocols
o Performance Qualification Protocols
o Traceability Matrix
o Summary Reports
o Standard Operating Procedures
  • Comprehensive knowledge of standard validation procedures.
  • Proficient in current Good Manufacturing Practices (cGMPs), Part 11 and Annex 11 requirements.
  • Collaborate with Quality Assurance, IT and other teams to perform computer system validation in efficient manner.
  • Following Good Documentation Practices to record and report test results as per FDA Compliance