Senior Validation Engineer: Lead cGMP Validation & Equipment

Replimune; United States; On-site; USD 152,000 - 197,000; Full time

Benefits offered by this job

Annual performance bonus

Equity/Stock options

Medical, dental & vision insurance

401k match

Paid holidays & year-end shutdown

Job summary

Replimune is seeking a Senior Validation Engineer to join the Framingham-based team. You will lead qualification activities, coordinate design, procurement, installation, and qualification of new equipment, and manage validation lifecycle documents in alignment with cGMP guidance.

The role focuses on maintaining validated state, managing change controls, and providing expert guidance to cross-functional teams while ensuring regulatory compliance and continuous improvement.

Qualifications

• Minimum seven years of validation, engineering, or operations experience.
• At least seven years in a cGMP environment.
• Experience with GMP utilities and equipment required.
• Strong technical writing, attention to detail, and cross-functional collaboration.
• Knowledge of cGMP, GDP, and regulatory requirements.
• Ability to work independently or in a team.

Responsibilities

• Lead validation activities across facilities, utilities, equipment, and systems.
• Coordinate design, procurement, installation, commissioning, and qualification of new assets.
• Develop and maintain validation project plans and lifecycle documents.
• Own validation procedures and requalification campaigns.
• Maintain validated state through change control and periodic reviews.
• Investigate deviations and CAPAs; support troubleshooting.
• Provide training on validation program elements.
• Stay informed on evolving regulatory guidance.

Skills

Validation leadership

Project management

Technical writing

Cross-functional collaboration

Attention to detail

Independence

Education

Bachelor’s degree in Science/Engineering

MSc/MS preferred

Tools

GMP utilities

Job description

Replimune is seeking a Senior Validation Engineer to join the Framingham-based team. You will lead qualification activities, coordinate design, procurement, installation, and qualification of new equipment, and manage validation lifecycle documents in alignment with cGMP guidance.

The role focuses on maintaining validated state, managing change controls, and providing expert guidance to cross-functional teams while ensuring regulatory compliance and continuous improvement.