Global Process Validation Engineer – Lifecycle Expert

BioMarin Pharmaceutical Inc.; Ireland; On-site; EUR 110,000 - 150,000; Full time

Job summary

BioMarin Pharmaceutical Inc. in Ireland seeks a Senior Engineer, Global Process Validation to lead lifecycle validation across drug substance manufacturing.

You will coordinate process validation, technology transfers, and lifecycle management for biologics and other modalities in a highly cross-functional setting. The role requires 8+ years in a cGMP-biotech environment, strong technical writing, regulatory liaison experience, and leadership of complex validation projects.

Qualifications

• Bachelor's degree in Chemical/Biochemical Engineering or related technical discipline required.
• Master's degree or advanced scientific degree is advantageous.
• Formal training in project management or quality risk management is advantageous.

Responsibilities

• Lead validation activities for late-stage to commercial drug substance processes.
• Develop risk-based validation strategies including design, qualification, and continued verification.
• Author and review validation master plans, protocols, reports, and risk assessments.

Skills

Process Validation Lifecycle

Quality Risk Management

Technical Assessment Development

Data Analysis

Project Management

Regulatory Compliance

Technical Writing

Cross-functional Leadership

Education

Bachelor's degree in Chemical/Biochemical Engineering or related

Master's degree is advantageous

Job description

BioMarin Pharmaceutical Inc. in Ireland seeks a Senior Engineer, Global Process Validation to lead lifecycle validation across drug substance manufacturing.

You will coordinate process validation, technology transfers, and lifecycle management for biologics and other modalities in a highly cross-functional setting. The role requires 8+ years in a cGMP-biotech environment, strong technical writing, regulatory liaison experience, and leadership of complex validation projects.