Senior Scientist Qualification
Senior Scientist Qualification
CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.
In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies.
The CSL Behring Recombinant Facility (RCF) in Lengnau is part of CSL's ongoing global expansion strategy to support the company's long-term growth plans.
The new plant in Lengnau will manufacture three recombinant coagulation factors to treat hemophilia A & B patients. Two of these productshave already received marketing approval and have been successfully launched. The Lengnau site project requires an investment of several hundred millions USD and will create around 300 new jobs when it is fully operational in 2019/2020.
Are you interested in being part of this exciting project?
We are looking for
This position requires experience in commissioning/qualification activities in the GMP environment of Life Sciences / Pharma / Biotech Upstream/Downstream or Fill Finish manufacturing facilities. The candidate should have good experience of all project phases, including design, procurement, construction, C&Q and operational readiness. During the period of establishing the new manufacturing site the position holder will be part of the facility program and coordinate as well as oversee commissioning and qualification activities as QA representative in the program matrix structure. In the operational phase of the plant the position holder is part of the Qualification / Validation team overseeing the yearly requalification activities and is responsible to represent QA in project based qualification activities.
Main Responsibilities and Accountabilities:
Is responsible as QA representative to oversee FAT and SAT activities including review of FAT protocols and FAT reports as well as SAT protocols and reports. The position holder ensures that the Quality by Design (QbD) principles are an integrated into all elements (URS, RA and RS) leading to qualification activities (DQ, IQ, OQ and PQ). The responsibilities include the review and approval of URS, RA, RS, FAT, SAT, DQ, IQ, OQ and PQ documents representing QA. The position holder may be part of the teams establishing DQ, IQ, OQ and PQ documents. A collaborative working approach between all stakeholders (e.g., Engineering and Services, Production, R&D, QC staff and others) ensures that qualification activities are planned and delivered in an efficient timeframe. Qualification scientists are involved in the preparation and attendance to health authority inspections within the area of responsibilities.
Qualifications & Experience:
We are looking for an experienced Engineer or Scientist with a few years' experience in commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech-or pharmaceutical industry. The successful candidate is fluent in German and has good English skills (written and spoken). Very good management skills and flexibility to manage task in a complex environment are required. Knowledge of pharmaceutical manufacturing in particularly of biotechnological drug substance manufacturing would be an asset.
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 Stöckacker, Bern, and later 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. For initial information you are welcome to contact Recruitment at +41 31 344 12 51.
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