Senior Validation Engineer I — Remote (up to 20%), GMP/ISO

Takeda Pharmaceutical Co.; Lexington (MA); On-site; USD 105,000 - 141,000; Full time

Benefits offered by this job

Remote work option

Job summary

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I to lead validation activities for facilities, utilities, equipment, cleaning, and sterilization systems at the Lexington, MA site.

You will collaborate with cross-functional teams to define validation strategies and lifecycle-based requirements, manage resources, and prepare final validation reports. The role requires a Bachelor’s degree in Mechanical Engineering with at least 30 months of related experience, IQ/OQ/PQ

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 30 months of related experience required.
• Experience with qualification protocols and reports for facilities, utilities, equipment, cleaning, and sterilization systems.

Responsibilities

• Perform validation programs for FEU, CIP/COP, sterilization, and analytical instruments.
• Coordinate validation activities and assemble final validation packages.
• Develop protocols, execute validation, and prepare final reports for GMP and FDA/ISO standards.

Skills

Validation

GMP

FDA Guidelines

IQ/OQ/PQ

Project management

Education

Bachelor’s degree in Mechanical Engineering

Job description

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I to lead validation activities for facilities, utilities, equipment, cleaning, and sterilization systems at the Lexington, MA site.

You will collaborate with cross-functional teams to define validation strategies and lifecycle-based requirements, manage resources, and prepare final validation reports. The role requires a Bachelor’s degree in Mechanical Engineering with at least 30 months of related experience, IQ/OQ/PQ