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.
Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers 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 Senior Scientist QC Equipment Qualification for a new sterile Drug product facility to support quality control related activities.
Key responsibilities:

• Lead and manage the initial and re-qualification of analytical equipment as per defined procedure
• Execution of performance qualification and act as a trainer for defined equipment and related processes
• Author, review and approve documentation (qualification plans and reports; documents from service providers) related to laboratory systems as required, following applicable SOPs and all current documentation practices.
• Ensure compliance of laboratory systems according to c GMP and current best practices and regulatory guidelines as well as respective SOP`s.
• Authoring of c GMP documents e.g. procedures (SOPs) or quality records (Deviations, Change requests)
• Oversight and guidance for proper maintenance and qualified state of equipment; Performing period review of qualification/calibration of analytical equipment
• Act as system owner for defined Equipment
• Participate as Subject Matter Expert in audits and inspections

Key requirements:

• Apprenticeship or academical degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
• Experience on current requirements / standards related to instrument qualification and corresponding documentation in pharmaceutical industries and c GMP controlled environment
• Broad experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS etc.
• Fluency in written and spoken English, German is an asset
• Capability to work independently and in a dynamic & fast-pacing project environment
• Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon

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.