Validation Expert (80-100%)

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><p>The Steriles Team within our Manufacturing Science and Technology (MSAT) department is a powerhouse of cross-functional expertise dedicated to the sterile production of parenteral Drug Products. We strive for innovation and the reduction of process time, evaluating scenarios to reduce costs while establishing lean and robust processes through the integration of innovative technologies like Single Use Technologies.</p><p></p><p>We are looking for a visionary Validation Expert to take ownership of product-related manufacturing processes, including validation, process monitoring, and product holding time (time out of storage). In this role, you will primarily be responsible for the validation of product-related manufacturing processes, supporting products during launches, technical transfers, and commercial manufacturing as a subject matter expert.</p><h3></h3><h3>The Opportunity</h3><ul><li><p>Conduct validation of product-related manufacturing processes for sterile drug products as part of various technical transfer teams while managing the lifecycle of validation processes and validated products.</p></li><li><p>Develop and improve local and global validation strategies for different products and specific topics like product Hold Time and Time out of Storage in collaboration with partners.</p></li><li><p>Support sterile manufacturing as a subject matter expert, including troubleshooting, continuous improvement, quality risk management, and PQS elements like Change, CAPA, and Deviation Management.</p></li><li><p>Collaborate with different functions in Kaiseraugst, other production sites, development teams, and global functions across the Roche/Genentech network.</p></li><li><p>Author relevant regulatory dossier sections and support the implementation of regulatory strategies in the context of product launches.</p></li><li><p>Apply Agile principles and LPS to design leaner, faster, and more robust validation processes that leverage cutting-edge technology to get medicines to patients sooner.</p></li><li><p>Maintain a fundamental understanding of sterile manufacturing, GMP, and regulatory requirements while demonstrating a strong drive for execution with a compliance focus.</p></li></ul><p></p><h3>Who You Are</h3><ul><li><p>A BS/BA degree in life sciences or engineering (advanced degree favorable) with multiple years of relevant bio/pharmaceutical experience, ideally in manufacturing, process validation, or technical development.</p></li><li><p>In-depth practical experience in a high-performance learning culture with a fundamental understanding of safety, quality systems, and quality assurance concepts, including cGMPs.</p></li><li><p>Distinct ability to work in a self-organized, multi-disciplinary team in an agile environment with a sense of urgency, high motivation, and a track record of driving change.</p></li><li><p>Strong communication and collaboration skills with a multitude of different stakeholders, communities, and external partners.</p></li><li><p>A solution-oriented &#34;can-do&#34; attitude and a mindset focused on organizational success, with fluency in both German and English.</p></li></ul><p></p><p>Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!</p><p></p><p><b> </b></p><p><b> </b></p><p></p><h3>Who we are</h3><p style="text-align:left">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.</p><p style="text-align:left"><br />Let’s build a healthier future, together.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Roche is an Equal Opportunity Employer.</b></p>