Senior Process Engineer: Tech Transfer & Scale-Up Lead

BioMarin Pharmaceutical Inc.; Irlanda; Ibrido; EUR 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

BioMarin Pharmaceutical Inc. is seeking a Senior Process Engineer in Cork, Ireland, to own end-to-end process responsibility for products manufactured at internal sites and CMOs/CDMOs.

The role requires deep engineering leadership from process selection through technology transfer, scale-up, PPQ, and lifecycle optimisation. The position safeguards product quality and regulatory compliance by ensuring processes are scientifically understood, transferable, and validated.

Competenze

• Bachelor’s degree or higher in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Engineering or a closely related technical discipline.
• 15+ years of progressive experience in biopharmaceutical or pharmaceutical process engineering and technical operations.
• Experience providing technical oversight to external manufacturing partners (CMOs/CDMOs) and governance.
• Leadership of technology transfers across sites, scale-up and PPQ activities.
• Deep hands-on experience in process fit-to-plant assessment, equipment gap analysis, scale-up and transfer risk management.
• Advanced practical experience with commercial biologics manufacturing across upstream and downstream processing.
• Proven success leading investigations, process validation and lifecycle changes with regulatory alignment.
• Strong knowledge of global cGMP, ICH guidelines, data integrity and regulatory inspection support.
• Statistical process monitoring, multivariate/data analysis, process capability and structured problem solving (FMEA, RCA, CAPA, Lean Six Sigma).
• Willingness to travel to external manufacturing sites as needed.

Mansioni

• Lead technical oversight for assigned processes at Internal and external CMOs/CDMOs.
• Manage technology transfer planning, gap assessments, and transfer readiness.
• Oversee scale-up, PPQ, and lifecycle validation activities.
• Maintain process knowledge, control strategy and data integrity.
• Collaborate with Quality, Regulatory, Engineering and Supply Chain to ensure compliant manufacturing.

Formazione

Bachelor’s or higher in Chemical/Biochemical/Biotechnology/Pharmaceutical Engineering (Master’s/PhD advantageous)

Descrizione del lavoro

BioMarin Pharmaceutical Inc. is seeking a Senior Process Engineer in Cork, Ireland, to own end-to-end process responsibility for products manufactured at internal sites and CMOs/CDMOs.

The role requires deep engineering leadership from process selection through technology transfer, scale-up, PPQ, and lifecycle optimisation. The position safeguards product quality and regulatory compliance by ensuring processes are scientifically understood, transferable, and validated.