About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Stellenbeschreibung

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

We are currently looking for a

Commissioning & Qualification 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:

• Bachelor/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


• Proven experiences


• Excellent written German and English, excellent


• Ability to communicate clearly and effectively


• Analytical thinking and problem-solving ability


• Self time management


• Excellent team player