Responsible for the commissioning and validation of production equipment and facilities for new and renovation projects, including writing protocols and reports, and executing validation documents to meet industry standards (GMP, GAMP 5, 21 CFR Part 11, ISO 14644) and Takeda quality system requirements
Job Summary
Responsible for the commissioning and validation of production equipment and facilities for new and renovation projects, including writing protocols and reports, and executing validation documents to meet industry standards (GMP, GAMP 5, 21 CFR Part 11, ISO 14644) and Takeda quality system requirements.
Supports computerized system validation and changes for production equipment, facilities, and production systems in new projects, and participates in cross-functional teams to define validation strategies and requirements based on the lifecycle concept.
Manages regular validation of production systems (e.g., production equipment, HVAC, pure water, compressed air, EMS) to ensure GMP compliance, and supports statistical tracking of engineering services performance related to validation.
Matching Summary
Responsible for the commissioning and validation of production equipment and facilities for new and renovation projects, including writing protocols and reports, and executing validation documents to meet industry standards (GMP, GAMP 5, 21 CFR Part 11, ISO 14644) and Takeda quality system requirements.
Skills & Requirements
Must-have
Production equipment and facility commissioning
Writing protocols and reports
Executing and interpreting validation documents
Computerized system validation
Cross-functional project team communication
Regular validation management
Quality engineering tools for problem solving
Nice-to-have
Risk analysis (FMEA, DOE, QbD, SPC)
Gap identification and remediation
Investigating and closing non-conformances
EHS policy and process execution
Key Requirements
Thorough understanding of cGMP, GAMP 5, and 21 CFR Part 11
Familiarity with relevant SOPs and project procedures