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The Process Validation Chapter is a part of the Basel Drug Substance Manufacturing organization and is responsible for supporting the validation of the production process during routine commercial manufacturing, technology transfers, process optimizations and for leading implementation of new technologies to drive manufacturing efficiencies.
You develop, execute, and implement process validation strategies and concepts. Furthermore:
Support technical process technology transfers e.g. from development to commercial scale manufacturing
End-to-end ownership of validation deliverables from conceptual work and plan creation to the implementation of necessary training and coordination of samples, to the interpretation of results and preparation of validation reports
Planning and coordination of troubleshooting activities in cooperation with the pilot laboratories, production and the quality department
Processing of deviations and changes according to GMP guidelines
Support for optimization projects
You hold a university degree (or equivalent training/experience) in a scientific or technical field. Preferably in the field of biotechnology, bioprocess engineering, or (bio)chemical engineering. Furthermore:
Experience in working in a GMP environment and ideally in the planning and implementation of process validation or characterization studies
You should be a team player who can work independently in a dynamic environment and enjoys collaborating with diverse interfaces
Ability to adapt to a rapidly changing environment with changing priorities and to respond flexibly to requests
Very good (also intercultural) communication skills
Fluent in German and English
Bioprocess knowledge and/or project management skills are a plus
Ready to make a difference? Apply now!
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.