Process Engineer Upstream Manufacturing (befristet für 1 Jahr)
Overview
Join Roche as a Process Engineer Upstream Manufacturing on a temporary basis for 1 year. You will be responsible for delivering solutions within the B91 Manufacturing Unit SUT (Single-use Technology) at Basel Drug Substance Manufacturing, ensuring safe and high-quality antibody production. Your role involves developing process improvements and fostering collaboration between local and global teams in development, innovation, and regulatory areas.
Responsibilities
Support shifts technically and scientifically for stable GMP-compliant processes, including on-call support.
Plan and coordinate troubleshooting and root cause analyses with relevant interfaces.
Handle planned and unplanned GMP events, review, and approve electronic batch records.
Ensure compliance with PQS and cGMP regulations.
Lead or support optimization projects and the introduction of new technologies/products.
Conduct and maintain quality risk assessments to reduce GMP risks.
Own production processes and serve as interface between Manufacturing, Science, and Technology.
Prepare and present concepts, documentation, and assessments during GMP audits and inspections.
Represent the site in network initiatives and communities if needed.
Candidate Profile
Degree in natural or engineering sciences, preferably biotechnology or bioprocess engineering.
At least 2 years of experience in GMP-regulated biopharmaceutical manufacturing, with knowledge of upstream processing.
Practical experience with large molecule drug substance processes, including steel or single-use technology, and technical transfers.
Hands-on experience in large molecule drug substance manufacturing processes.
Team-oriented, independent working style with strong communication skills in local and global teams.
Fluent in German and English, both spoken and written.
Application
Apply now with your current CV and relevant certificates to become part of our team and help shape the future!
About Roche
We are committed to building a healthier future through innovation. With over 100,000 employees worldwide, we are dedicated to advancing science and ensuring healthcare access for all. Our efforts have helped treat over 26 million people and conduct more than 30 billion diagnostic tests. We foster creativity, explore new possibilities, and aim to deliver life-changing healthcare solutions.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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