CSL Behring - the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions. CSL is a subsidiary of CSL Limited, headquartered in Melbourne, Australia.
In Lengnau a new manufacturing site is being built, CSL Behring Recombinant Facility AG, for the development and manufacture of life-saving therapies. These products help people with haemophilia to live full lives.
Innovative and committed to patients around the world.
Leading-edge medicines made in Bern and soon also in Lengnau.
Are you interested in being part of this exciting project?
We are looking for an experienced
Project Engineer DSP
The main responsibilities of this position are:
The position holder acts as Downstream Project Engineer.
He reports to the Dir. Bulk Process Technology and Building Lead B&E.
The position holder is responsible that the requirements from production regarding processes are the base for the engineering of the equipment, layout, rooms through Detailed Design, Construction, Commissioning, Qualification and Start Up within building B and partially E (dispensing).
The position holder contributes to the design of the maintenance system
Main Responsibilities and Accountabilities:
Works on Process design, inputting across the bulk facility in accordance with the approved design, local codes and cGMP regulatory requirements.
Supports the Senior Manager DSP for interface with others project responsibles (Fill&Finish, USP, Media&Buffer, Utilities, Construction, etc...) in the project in order to assure overall coordination of the timelines and resources.
Liaises with customer groups on the project to ensure delivery according to user requirements, process best practices, in accordance with quality and safety requirements.
Inputting to the group Engineering bulk technology and interacts with the project team according to the project schedule and requirements as well as the needs of the future established Engineering Services organization.
Support of the Maintenance Groups in the definition of the maintenance system and the maintenance schedule for DSP in building B.
Responsible and accountable for working according to cGxP, health, safety and environmental requirements as laid out in the CSL SOPs and procedures as well as all relevant external / governmental guidance.
Inputting for all projects (engineering) requirements specifications, requirement specifications etc. dealing with the DSP processes
Technical support for procurement, FAT & SAT of all process equipment & skids.
interact and coordinate the design/ construction/ commissioning/ qualification teams for DSP process technology and equipment to ensure that the mechanical completion, commissioning and IQ/OQ/PQ steps are achieved in line with the master schedule and support the startup of interdependent functional areas.
Active involvement in issue resolution, assisting cross-functional teams and attending coordination meetings between the various engineering disciplines leads to ensure smooth installation, construction and commissioning of the facility.
Qualifications & Experience:
Education: Degree (Bachelor, Masters or higher) in mechanical or process engineering, Dipl. Ing. or B.Sc. or M.Sc. or equivalent.
Several years of experiences in the pharmaceutical-, chemical- or food industry as a project engineer or manager.
Experiences in project management including contract management and controlling.
Experiences in cGxP and qualification
Languages: German and English fluent in written and spoken
Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?
Offices will be in Lengnau.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these together with the CV in one document.