C&Q Engineer

As a successful C&Q Engineer you ensure that Commissioning and Qualification are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing commissioning and qualification for CAPEX- and OPEX-projects at CSL Behring. In detail, your responsibilities include: Planning, coordination and execution of all phases for commissioning and qualification of GMP manufacturing systems according to local and global procedures and standards as well as legal requirements. Facilitating the development, performing review and approving technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation) Development of C&Q verification documents including but not limited to Commissioning/ Qualification plans, FMEA, IQ, OQ as well as for the execution of verification activities Coordination and oversight of vendor FAT/SAT, commissioning activities in collaboration with internal and external partners Planning and execution of PQ's including sterilization / depyrogenisation cycle development, Smoke Study, Temperature/Humidity mapping Assessing and handling of Change Controls, CAPAs and Non-Conformances related to qualification topics Work collaboratively with all stakeholders, Process Engineering, Project Delivery, Execution Systems, PALM Validation, PALM Stability, Value Streams, R&D, QC staff and others, to ensure that activities are planned and delivered in an efficient timeframe Provide support and management to the multi-site projects to deliver on the company key CapEx projects Who you are: Master degree in a relevant science or engineering discipline Proven work experience in biotech or pharma company in an cGxP environment and/or C&Q equivalent position Experience and knowledge in sterilization / dehydrogenization is a plus Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines Excellent written German and English Ability to communicate clearly and effectively Analytical thinking and problem-solving ability Self-time management Excellent team player Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organisation with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring

Location: bremgarten-bei-bern, CH

Posted Date: 11/25/2024