Senior Validation Engineer I — Remote (Up to 20%)

USA - 3383 Shire Human Genetic Therapies, Inc.; Lexington (MA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Shire Human Genetic Therapies, Inc. located in Lexington, MA, is seeking a Senior Validation Engineer I to lead validation programs across facilities, utilities, equipment, cleaning, and sterilization.

You will collaborate with cross-functional teams to develop lifecycle-based validation strategies and manage project plans. The role requires a Mechanical Engineering degree and 30 months of related experience, with expertise in IQ/OQ/PQ, deviations, CAPA, and preparing final validation reports.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field, plus 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.
• Experience performing commissioning and qualification (IQ/OQ/PQ) of manufacturing systems including automation platforms and analytical instruments.
• Experience managing 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.
• Full time.

Responsibilities

• Perform validation programs for FEU, cleaning, sterilization, and analytical instruments.
• Collaborate with cross-functional project teams to define validation strategy.
• Manage validation projects including resource planning and status updates.
• Prepare validation protocols, reports, and final packages for qualification.
• Review and approve validation documents and responses to inspections.

Skills

Project Management

Validation

Cross-functional Collaboration

Documentation

Education

Bachelor’s degree in Mechanical Engineering or related field

Job description

Shire Human Genetic Therapies, Inc. located in Lexington, MA, is seeking a Senior Validation Engineer I to lead validation programs across facilities, utilities, equipment, cleaning, and sterilization.

You will collaborate with cross-functional teams to develop lifecycle-based validation strategies and manage project plans. The role requires a Mechanical Engineering degree and 30 months of related experience, with expertise in IQ/OQ/PQ, deviations, CAPA, and preparing final validation reports.