Lead Global Process Validation Engineer

BioMarin Pharmaceutical Inc.; Cork; Híbrido; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

BioMarin Pharmaceutical Inc. seeks a Senior Engineer, Global Process Validation in hybrid Cork to lead lifecycle validation and technical assessments across biologics, small molecules, peptides, and oligonucleotides.

Responsibilities include validation strategy design, technology transfers, and regulatory-ready documentation, with collaboration across Manufacturing, Regulatory, Quality, and Engineering. This role requires strong project leadership and experience in a cGMP environment.

Formación

• Bachelor’s degree in a chemical/biochemical engineering or related technical discipline required.
• Master’s degree or advanced scientific degree advantageous.
• Formal training in project management or quality risk management advantageous.

Responsabilidades

• Lead process validation activities for drug substance manufacturing processes from late-stage development through commercial lifecycle management.
• Develop and execute risk-based validation strategies consistent with lifecycle process validation principles, including process design, qualification, and continued verification.
• Author and review validation master plans, protocols, reports, risk assessments, technical assessments, and supporting regulatory documentation.
• Support implementation of new processes, process changes, site transfers, and capacity expansion projects.
• Perform technical evaluations supporting manufacturing process changes, deviations, investigations, CAPAs, and change controls.
• Lead process impact assessments and risk-based evaluations using tools such as FMEA and quality risk management methodologies.
• Collaborate cross-functionally to ensure successful project execution.
• Support generation and review of CTD sections and responses to regulatory questions.

Educación

Bachelor’s degree in Chemical/Biochemical Engineering, Engineering, Biological Sciences, Pharmaceutical Sciences, Chemistry, or related technical discipline

Master’s degree or advanced scientific degree

Formal training in project management or quality risk management

Descripción del empleo

BioMarin Pharmaceutical Inc. seeks a Senior Engineer, Global Process Validation in hybrid Cork to lead lifecycle validation and technical assessments across biologics, small molecules, peptides, and oligonucleotides.

Responsibilities include validation strategy design, technology transfers, and regulatory-ready documentation, with collaboration across Manufacturing, Regulatory, Quality, and Engineering. This role requires strong project leadership and experience in a cGMP environment.