Process Validation Engineer

Roche seeks a Process Validation Engineer in Basel to lead validation strategies for drug substance manufacturing, ensuring compliance and efficiency during routine production and technology transfers.

Positioned within the Basel Drug Substance Manufacturing organization, this role focuses on validating production processes for commercial manufacturing, technology transfers, and process optimizations. The engineer leads the implementation of new technologies to enhance manufacturing efficiencies and ensures rigorous adherence to quality standards.

Responsibilities

• Create and apply strategies for process validation.
• Facilitate technical transfers from development stages to commercial-scale production.
• Manage validation deliverables from initial planning through training, sample coordination, result analysis, and final reporting.
• Coordinate troubleshooting efforts with pilot labs, production teams, and quality assurance.
• Handle process deviations and changes in compliance with GMP regulations.
• Assist in projects aimed at optimizing existing processes.

Requirements

• A university degree or equivalent background in a scientific or technical discipline.
• Prior experience working within a Good Manufacturing Practice (GMP) setting.
• Fluency in both German and English.
• Flexibility to adapt to shifting priorities in a fast-paced environment.
• Strong communication abilities, including intercultural competence.
• Ability to work independently while collaborating effectively with diverse teams.

Nice to have

• A degree in biotechnology, bioprocess engineering, or chemical engineering.
• Hands-on experience in planning and executing process validation or characterization studies.
• Knowledge of bioprocesses or project management expertise.

About the company

Roche is a global healthcare company with over 100,000 employees dedicated to advancing science to prevent, stop, and cure diseases. The organization strives to ensure everyone has access to healthcare while empowering its workforce to explore new possibilities, foster creativity, and maintain high ambitions. The culture promotes open dialogue, personal expression, and genuine connections, ensuring employees feel valued, accepted, and respected.

• Encourages personal expression and open dialogue.
• Fosters genuine connections where employees are valued and respected.
• Dedicated to preventing, stopping, and curing diseases globally.
• Empowers staff to explore new possibilities and keep ambitions high.