Validation Engineer

Takeda

Tianjin, China
Production equipment and facility validation
Cgmp, gamp 5, 21 cfr part 11
Cross-functional project teams
Responsible for the commissioning and confirmation of production equipment and facilities for new and renovation projects, including writing protocols and reports, and executing, interpreting, and evaluating validation documents

Job Summary

  • Responsible for the commissioning and confirmation of production equipment and facilities for new and renovation projects, including writing protocols and reports, and executing, interpreting, and evaluating validation documents.
  • Supports computerized system validation and changes for production equipment, facilities, and production systems in new projects.
  • Manages regular validation of production systems such as production equipment, HVAC, pure water, compressed air, and EMS to ensure GMP requirements are met.

Matching Summary

Responsible for the commissioning and confirmation of production equipment and facilities for new and renovation projects, including writing protocols and reports, and executing, interpreting, and evaluating validation documents.

Skills & Requirements

Must-have

  • production equipment and facility validation
  • cGMP, GAMP 5, 21 CFR Part 11
  • cross-functional project teams
  • quality engineering tools
  • EHS policies and procedures

Nice-to-have

  • risk analysis
  • statistical tracking
  • compliance gap identification

Key Requirements

  • Bachelor's degree in a relevant field
  • Experience with validation equipment
  • Understanding of cGMP, GAMP 5, and 21 CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter