Senior Process Engineer - Biopharma Tech Transfer Lead

Next Generation (Ireland); Dublin; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Next Generation (Ireland) is seeking a Senior Process Engineer to transfer and scale new products and manufacturing processes in a biopharmaceutical setting. You will lead cross-functional investigations, apply advanced data analysis, and drive process improvements to meet quality and regulatory standards.

Based in Dublin, this 12-month contract involves technology transfer, CAPA implementation, and collaboration with engineering, manufacturing and quality teams to deliver project objectives.

Formación

• Bachelor's degree or higher in Chemical Engineering, Biological Engineering, Biological Sciences, Chemistry or related discipline.
• Approximately 5+ years' relevant experience with an MSc or 7+ years with a BSc.
• Experience in pharmaceutical, biotechnology or biopharmaceutical manufacturing.
• Working knowledge of GMP and regulatory requirements.
• Experience in Technology Transfer and/or New Product Introduction (NPI).
• Knowledge of biologics manufacturing, particularly upstream cell culture, downstream purification or commercial-scale drug substance production.
• Exposure to process development, characterisation, validation or Process Performance Qualification (PPQ).
• Familiarity with Lean Six Sigma, Design of Experiments (DOE), JMP, SPC, MVDA or Process Analytical Technology (PAT).
• Strong technical investigation, problem-solving and communication skills, with the ability to work independently.

Responsabilidades

• Support the introduction and transfer of new products and manufacturing processes.
• Lead cross-functional investigations into process deviations, identifying root causes and implementing CAPA.
• Drive process improvements through Lean Six Sigma projects, Kaizen events and structured problem-solving.
• Apply data analysis to identify process trends, improve performance and support technical decision-making.
• Support change control, risk assessments and manufacturing readiness activities.
• Collaborate with engineering, manufacturing and quality teams to deliver project objectives.

Conocimientos

Lean Six Sigma

Data analysis

Problem-solving

Communication

Cross-functional collaboration

Educación

Bachelor's degree or higher in Chemical Engineering, Biological Engineering, Biological Sciences, Chemistry

Herramientas

JMP

SPC

PAT

DOE

MVDA

Descripción del empleo

Next Generation (Ireland) is seeking a Senior Process Engineer to transfer and scale new products and manufacturing processes in a biopharmaceutical setting. You will lead cross-functional investigations, apply advanced data analysis, and drive process improvements to meet quality and regulatory standards.

Based in Dublin, this 12-month contract involves technology transfer, CAPA implementation, and collaboration with engineering, manufacturing and quality teams to deliver project objectives.