As a Process Engineer Downstream, you will deliver solutions in the B91 Manufacturing Unit SUT (Single-use Technology) at Basel Drug Substance Manufacturing for safe and high-quality antibody production. You will serve both our patients and our staff by developing and implementing process improvements and fostering dialogue and collaboration between local and global functions in the areas of development, innovation and regulation. Within our RePeng (Recipe and Process Engineering) team, we are looking for you as a Process Engineer to optimize our downstream processes.
The perfect candidate has a degree and at least 3 years of professional experience and correspondingly extensive knowledge in the field of downstream processing and/or upstream processing of biotechnologically manufactured products. Furthermore, a minimum of 2 years of experience in biopharmaceutical manufacturing or development is required, as well as experience working in a cGMP environment.
General information
* Planned duration of employment: 12 months
* Extension: rather unlikely, in case of project extension
Tasks & Responsibilities
* Technical and scientific support of the shifts to ensure robust and efficient manufacturing processes in the GMP environment, as well as on-call service.
* Planning and coordination of troubleshooting activities and root cause analysis in close cooperation with the other Manufacturing Units, Quality, MSAT and other departments.
* Dealing with planned and unplanned events according to GMP guidelines (Planned / unplanned events).
* Review and approval of electronic batch records for commercial and clinical products (MES-based batch record review).
* Act in accordance with the requirements of the internal quality system (PQS) and the cGMP regulations of the health authorities.
* Leading or supporting optimization projects and introducing new technologies or products.
* Plan, prepare, facilitate, conduct, summarize, review and update new and existing quality risk assessments in the context of commercial manufacturing to ensure systematic identification and reduction/elimination of GMP compliance risks.
* Owner of the production processes (interface areas Manufacturing, Science and Technology).
* Preparation and presentation of concepts, documents and assessments during GMP audits and inspections by authorities.
* If necessary, representation of location network initiatives and in network communities.
Must haves
* Degree in natural sciences or engineering or degree in biotechnology or bioprocess engineering
* preferred
* Min. 3-5 years of experience and correspondingly extensive knowledge in the field of downstream processing *****
* Min. 2 years of experience in biopharmaceutical manufacturing or development*****
* Experience working in cGMP environment*****
* Hands-on experience in Large Molecules Drug Substance manufacturing processes in steel or single-use technology is an advantage***
* Experience in technical transfers and quality risk management (QRM) is an advantage**
* Team player with a very high degree of independence in a self-directed environment
* Excellent communication skills when interacting in the team, local and global interfaces
* Enjoyment of working in global teams
* Local working language is German therefore very good knowledge of German and writing required
* Excellent written and spoken German and English skills
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