Senior Validation Engineer I — Hybrid GMP/ISO Focus

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

Benefits offered by this job

Remote work up to 20%

Job summary

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I in Lexington, MA to lead validation programs for facilities, utilities & equipment, sanitation, and automation systems.

You will coordinate cross-functional teams, develop qualification strategies, and manage validation documentation through final reports. The role requires a bachelor’s degree in mechanical engineering or related field, plus experience in IQ/OQ/PQ, CAPA, and regulatory compliance.

Qualifications

• Develop and execute qualification protocols and reports for facilities, utilities, equipment, cleaning, and sterilization systems (21 CFR 210/211).
• Manage validation projects including resource planning, tracking progress, and communicating status to cross-functional stakeholders.
• Investigate deviations and implement CAPA while identifying validation compliance gaps against GMP and ISO 14644 standards.

Responsibilities

• Develop protocols, coordinate validation activities, qualify/validate execution, prepare final reports & assemble final validation packages.
• Generate protocols & reports, execute & evaluate validation documents for industry standards (GMPs, FDA Guidelines).
• Author deviations/discrepancies & updates to site validation plans & manage annual execution schedules.

Skills

Qualification protocols

IQ/OQ/PQ

Validation management

CAPA

Education

Bachelor’s degree in Mechanical Engineering or related field

Job description

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I in Lexington, MA to lead validation programs for facilities, utilities & equipment, sanitation, and automation systems.

You will coordinate cross-functional teams, develop qualification strategies, and manage validation documentation through final reports. The role requires a bachelor’s degree in mechanical engineering or related field, plus experience in IQ/OQ/PQ, CAPA, and regulatory compliance.