Senior Engineer, Global Process Validation - Hybrid

BioMarin Pharmaceutical Inc.; Cork; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

BioMarin Pharmaceutical Inc. is seeking a Senior Engineer, Global Process Validation in Cork, Ireland.

The role leads lifecycle validation for drug substances, coordinating cross-functional teams across manufacturing, quality, regulatory, and engineering to ensure compliant processes from late-stage development through commercial use. The position requires extensive cGMP experience, strong technical writing, and leadership in validation projects with a focus on biologics/advanced therapies.

Qualifications

• Bachelor's degree in a chemical/biochemical engineering, biology, pharma science, chemistry or related discipline.
• Master's degree or advanced science degree is advantageous.
• Formal training in project management or quality risk management is advantageous.

Responsabilités

• Lead process validation activities for drug substance manufacturing from late-stage to commercial lifecycle.
• Develop and execute risk-based validation strategies across lifecycle stages.
• Author and review validation master plans, protocols, and regulatory documentation.
• Support implementation of new processes, site transfers, and capacity expansions.
• Perform technical evaluations for changes, deviations, investigations, CAPAs, and changes.
• Lead risk-based evaluations using FMEA and quality risk management tools.
• Collaborate with cross-functional teams to ensure project execution.
• Support CTD sections and regulatory responses.
• Provide technical oversight for extractables/leachables, container closure, material compatibility, and single-use tech.
• Review toxicological risk assessments and supplier data.
• Coordinate with contract manufacturers and internal sites.
• Participate in regulatory inspections and audits as SME.
• Identify opportunities to improve validation systems and processes.
• Mentor junior engineers in validation principles and decision making.

Connaissances

Process Validation Lifecycle

Quality Risk Management

Technical Assessment Development

Microbial & Contamination Control

Process Characterization

Technology Transfer

Change Control

Data Analysis & Statistics

Project Management

Regulatory Compliance

Technical Writing & Communication

Cross-functional Leadership

Formation

Bachelor's degree in Chemical/Biochemical Engineering or related

Master's degree or advanced scientific degree advantageous

Project management or quality risk management training advantageous

Description du poste

BioMarin Pharmaceutical Inc. is seeking a Senior Engineer, Global Process Validation in Cork, Ireland.

The role leads lifecycle validation for drug substances, coordinating cross-functional teams across manufacturing, quality, regulatory, and engineering to ensure compliant processes from late-stage development through commercial use. The position requires extensive cGMP experience, strong technical writing, and leadership in validation projects with a focus on biologics/advanced therapies.