Senior Validation Engineer I — Remote (Up to 20%) & GMP/FDA

BioLife Plasma; Lexington (MA); Hybrid; USD 105,000 - 141,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Job summary

Takeda in Lexington, MA, seeks a Senior Validation Engineer I to lead validation programs across FEU, CIP/COP, sterilization, and software validation. You will drive lifecycle planning, collaborate with OpEx/CapEx teams, and manage budgets and timelines while ensuring GMP/ISO compliance.

Strong project management, regulatory knowledge, and CAPA experience are required; up to 20% remote work is allowed. Competitive salary and comprehensive benefits offered.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field with relevant validation exposure.
• Experience developing and executing qualification protocols (IQ/OQ/PQ).
• Familiarity with GMP, ISO 14644, and FDA guidelines.

Responsibilities

• Lead validation programs for facilities, utilities, equipment, cleaning, and sterilization.
• Coordinate cross-functional validation strategy and lifecycle documentation.
• Manage budgets, schedules, and resource forecasting for projects.
• Prepare final validation reports and manage responses to inspections.

Skills

IQ/OQ/PQ

Validation Protocols

Project Management

Regulatory Compliance

CAPA investigations

GMP/ISO 14644 awareness

Education

Bachelor9s in Mechanical Engg or related

30+ months related experience

Job description

Takeda in Lexington, MA, seeks a Senior Validation Engineer I to lead validation programs across FEU, CIP/COP, sterilization, and software validation. You will drive lifecycle planning, collaborate with OpEx/CapEx teams, and manage budgets and timelines while ensuring GMP/ISO compliance.

Strong project management, regulatory knowledge, and CAPA experience are required; up to 20% remote work is allowed. Competitive salary and comprehensive benefits offered.