Process Expert BIO/VE

<p style="text-align:left"><b>Job Description Summary</b></p>#LI-onsite<br><br>Location: Puurs, Belgium<br><br>Internal Job tital: Process expert<br><br>As Process Expert you will provide front line expert support for all process-specific issues to the manufacturing departments within compounding, filling Step into a role where your expertise drives innovation and quality in pharmaceutical manufacturing. As a Process Support Expert VE/BIO, you’ll be at the heart of our compounding, filling, and packaging operations—ensuring every batch meets the highest standards of Quality, safety and compliance. You’ll collaborate with cross-functional teams to optimize processes, resolve issues, and champion continuous improvement. This is your opportunity to shape the future of biologics and visco-elastics at Novartis, while making a real impact on patients’ lives.<p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Job Description</b></p><h2>Key Responsibilities</h2><ul><li><p>Provide expert front-line support to manufacturing teams across compounding, filling, and packaging operations</p></li><li><p>Ensure safe, timely, and compliant batch production aligned with quality and standards</p></li><li><p>Act as Subject Matter Expert (SME) for product and process knowledge within VE/BIO operations</p></li><li><p>Evaluate and troubleshoot product and process-related issues as first-line support</p></li><li><p>Maintain manufacturing processes at inspection readiness and regulatory compliance</p></li><li><p>Own and update master manufacturing documents to reflect current standards and changes</p></li><li><p>Lead deviation investigations, root cause analysis, and CAPA development and execution</p></li><li><p>Manage complaint handling and support Health Authority inspections</p></li><li><p>Identify and implement process improvements to enhance efficiency and quality</p></li><li><p>Challenge existing manufacturing practices to drive continuous improvement and innovation</p></li><li><p>Coordinate Operational excellence for the VE and BIO processes</p></li></ul><h2></h2><p></p><h2>Essential Requirements</h2><ul><li><p>Degree in a scientific field such as Pharmaceutical Sciences, Biomedical Sciences, or Engineering</p></li><li><p>Minimum 3 years of experience in GMP-regulated pharmaceutical operations</p></li><li><p>Strong understanding of pharmaceutical processes, regulatory standards, and quality systems</p></li><li><p>Fluent in Dutch with good proficiency in English</p></li><li><p>Strong analytical thinking and problem-solving skills</p></li><li><p>Excellent communication and stakeholder management abilities</p></li></ul><h2></h2><p></p><h2>Desirable Requirements</h2><ul><li><p>Experience with validation, deviation handling, and CAPA implementation</p></li><li><p>Knowledge of aseptic techniques and biotech manufacturing environments</p></li></ul><p></p><p></p><h2>What You Can Expect from Us</h2><p></p><p>You’ll join an open and stimulating company culture where collaboration, growth, and well being are at the heart of everything we do. We offer you the opportunity to develop yourself and expand your knowledge across various domains.</p><p>At our Puurs site, we place great importance on both the physical and mental well-being of our employees. That’s why we provide a supportive work environment that includes: a bike leasing program, an on-site fitness facility freely accessible to employees, and the presence of a mental coach on site.</p><p></p><h2><b>Commitment to Diversity and Inclusion</b></h2><p></p><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.</p><p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Skills Desired</b></p>Data Analytics, digital skills, General Hse Knowledge  , gmp knowledge, process excellence, Resilience