Senior Validation Engineer I — GMP/ISO Validation Lead

Takeda; United States; Hybrid; USD 105,000 - 141,000; Full time

Job summary

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I to lead validation programs across facilities, utilities, and equipment, including CIP/COP and sterilization systems.

The role includes developing protocols, coordinating validation activities, and preparing final reports to meet GMP/ISO standards. The candidate will manage projects, track progress, and communicate status to stakeholders while supporting regulatory inspections and CAPA processes.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 30 months of related experience.
• Experience developing and executing qualification protocols and reports for facilities, utilities, equipment, cleaning, and sterilization systems in compliance with 21 CFR 210/211; IQ/OQ/PQ of manufacturing systems including automation platforms and analytical instruments; manage validation projects with resource planning and cross-functional communication.

Responsibilities

• Perform validation programs for FEU, CIP/COP, sterilization, computer system validation, and analytical instrument qualification.
• Coordinate validation activities, prepare final reports, and assemble validation packages for qualification activities.
• Develop protocols, execute and evaluate validation documents to meet GMP and ISO standards; manage deviations and CAPA and support inspections.

Education

Bachelor’s degree in Mechanical Engineering or related field

Job description

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I to lead validation programs across facilities, utilities, and equipment, including CIP/COP and sterilization systems.

The role includes developing protocols, coordinating validation activities, and preparing final reports to meet GMP/ISO standards. The candidate will manage projects, track progress, and communicate status to stakeholders while supporting regulatory inspections and CAPA processes.