QC Lab Systems Specialist 80-100% (m/f/d)

Switzerland, Basel

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 QC Lab Systems Specialist.

Key responsibilities

  • Qualification/validation of analytical equipment in Phys. Chem. and Bioanalytics QC laboratories

  • Writing key qualification documents including: URS, Risk Assessment, OQ/PQ Plans and Reports

  • Supervise testing (IQ, OQ, PQ)

  • Review and approve qualification/validation related reports as required following cGxP

  • Maintain equipment in Phys. Chem. and Bioanalytics QC laboratories in alignment with relevant SOPs  

  • Collaborate with cross functional teams and stakeholders

  • Act as subject matter expert for laboratory system qualification within audits and inspections

  • Act as administrator for dedicated lab systems as per defined SOPs and instructions

Key requirements

  • Degree in e.g. Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering or on the job training as an Analytical Lab Technician

  • >Extensive experience in analytical equipment qualification and software validation

  • Excellent understanding of relevant regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP5)

  • Knowledge of quality management systems (e.g. TrackWise) is a plus

  • Good communication skills

  • Ability to work in a highly dynamic environment

  • Good inter-personal skills

  • Good knowledge of English (written and spoken)

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: R52472