Senior QA Expert – Clean Utilities &… at Lonza Group · Stein

Senior QA Expert – Clean Utilities & Facilities (m/f/d) 80-100% Location: CH - Stein The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Join our growing Drug Product Services team and help shape the future of pharmaceutical manufacturing! In this role, you’ll take the lead and oversight on qualification and validation activities for state-of-the-art infrastructure and utilities (i.e. clean water (WFI and Purified water), clean steam, compressed gases (air and nitrogen), clean rooms (from CNC to class A), and HVAC) supporting our aseptic fill & finish lines. You’ll contribute to high-impact CAPEX and OPEX projects while ensuring inspection and operational readiness in a cutting-edge environment. Are you looking for a chance to be part of an international and supportive team? Apply today! What you will get: An agile career and a dynamic work culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below. Benefits in Stein: https://bit.ly/42DlBDk What you will do: Act as responsible QA for establishment, execution and maintenance of infrastructure & clean utilities related qualification/validation activities in order to allow manufacturing of sterile medicinal products Acts as contact person for GMP related issues (deviations) and their proper handling in shared global QMS systems (e.g. Trackwise, Kneat) Ensure proper qualification strategy for infrastructure/ clean utilities by adherence to the corresponding site VMP(s), Regulatory requirements as well as Global and Local procedures during CAPEX and/or OPEX Projects Supervise activities like GMP status and trending of (re-) qualification/(re-) validation, adherence to global and local procedures for changes control management, deviations and CAPAs handling Act as SME for qualification related topics during audits and inspections Acts as contact person for qualification documents life cycle management e.g. approval of SOPs, qualification protocols and reports What we are looking for: Solid experience in qualification and validation of clean utilities & facilities (i.e. clean water (WFI and Purified water), clean steam, compressed gases (air and nitrogen), clean rooms (from CNC to grade A) and HVAC) for aseptic drug product manufacturing in a GMP environment is a must Experience with health authorities Audit (e.g. Swissmedic, FDA) and Customer inspections Knowledge of regulatory guidelines GMP Annex 1, 11, 15 Degree in life science (e.g. chemistry, biology, pharmacy) or equivalent experience You value working in a team, supporting your colleagues and contributing to a positive work culture is a matter of course to you Fluency in English is a must, German language skills are an advantage About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.