QA Expert Equipment Qualification and Validation, CSV & DI 80-100% (m/f/d) Our Offering Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Our Company About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Performance People Planet Community Global Quality Responsible Sourcing Careers Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Contact Our Offering Corporate Biologics Mammalian Microbial ADCs / Bioconjugates Drug Product mRNA / LNP Expression Technologies Small Molecules Drug Substance (API) Particle Engineering Drug Product Cell & Gene Process Development cGMP manufacturing Allogeneic Autologous Viral Vectors Bioscience Products Capsules & Health Ingredients Pharmaceutical Solutions Nutraceutical Solutions Back Our Company Corporate About Us Purpose and Strategy Leadership History Locations Site Tours Partnering with Us Events News and Media News Releases Images and Videos Logo Guidelines Blog Podcast Journalist Inquiries Investor Relations Shareholder Information Agenda and Events Financial Reporting Annual and Sustainability Report Corporate Governance Ethics and Compliance Investor Inquiries Sustainability Performance People Planet Community Global Quality Responsible Sourcing Back Careers Corporate Overview Life at Lonza What We Offer Career Stories Job Search Join Our Talent Community Recruitment Process Students, Graduates and Apprentices Back Contact Corporate Back QA Expert Equipment Qualification and Validation, CSV & DI 80-100% (m/f/d) Switzerland, Stein Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as QA Expert Equipment Qualification and Validation, CSV and DI 80-100% (m/f/d) being responsible to implement and maintain the commissioning, process validation, qualification of equipment and computerized systems (CQV) in the manufacturing site of Lonza DPS Stein. Key responsibilities: Design an E2E DI/CSV Roadmap for the IT infrastructure and pertaining systems for the Growth Facility, ensure proper Quality Systems Design as well as Quality Oversight Act as Single Point of Contact providing Quality Oversight for all DI/CQV (Life Cycle Management) Projects executed for the Growth Project Ensure implementation and Quality oversight for the Risk Management Process and periodical reviews pertaining to the DI / CQV Strategy in Line with LEAN Design Principles Continuously improves the DI Maturity Level of the Dolphin Facility towards Excellence Review, Assess and Approve all Documents pertaining to CQV Projects and DI  Establish a robust review mechanism to ensure maintaining the validated status of DI / CSV over given review cycles Providing guidance, expertise and coaching, assisting sites and their teams for policies, procedures and specifications. Serve as a Coach / Mentor for Network Key Talents in order to ensure talents development Key requirements: Academical degree (Bachelor or higher) in a Life Sciences, Engineering; IT Systems, Industrial Engineering or related science discipline Strong experience in CSV and Data Integrity within a GMP regulated environment Significant working experience in a QA role within the pharma industry Aseptic production experience Fluency in English, German would be an asset Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Reference: R56985 Apply Ways to Contact Contact Us Regulatory Support Locations Site Tours Partnering with Us Resources Knowledge Center Meet the Experts Upcoming Events Terms & Conditions Terms and Conditions Legal Disclaimer Privacy Policy California CCPA Notice Transparency in Coverage Lonza.com Company Overview News & Media Investor Relations Sustainability Careers © 2024 Lonza. All rights reserved. Cookie Settings