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
The main responsibilities of this position are:
The position holder is responsible and accountable for the development, execution and qualification/validation of computerized System. Support of CapEx-Projects in all phases. Coordination of Supplier for Software development for Process Control System (PCS).
Main Responsibilities and Accountabilities:
Responsible and accountable for the project management of approved CapEx-projects for computerized Systems (PCS) including the design and development in order to enable the startup, the commissioning and the validation of the PCS at CSL LGN site.
Coordinate with others project engineers (ex. MES, BMS) 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, in accordance with quality and safety requirements.
Develops the PCS and delivers according to the project schedule and requirements as well as the needs of the future established organization
Provide the necessary support and management for multi-site projects to deliver automation expertice for the company's key projects.
Support the Leader of PCS/MES Group in the setting up of the new Quality Management System, including SOPs for qualification and requirement for computerized Systems (PCS)
Support of the Maintenance Groups in the definition of the maintenance system and to improve the know how to support and maintain computerized systems (PCS)
Responsible and accountable for work 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.
Contributing to the delivery of the company strategy as well as supporting the financial CapEx budgeting process.
Responsible and accountable for all projects (computerized Systems) related documents such as qualification (DQ, IQ, OQ, PQ), User requirements specifications, requirement specifications etc. dealing with the PCS.
Qualifications & Experience:
Education: Degree (bachelor, masters or long experience in an equivalent position) in automation-, electro- or electronic- engineer, Dipl. Ing. or M.Sc. or B.Sc. or equivalent.
Several years of successful project execution and major projects for computerized systems with high complexity and interfaces with MES, BMS in the chemical, biotech-or pharmaceutical industry.
Proven project execution skills including document development and software implementation.
Proven experiences and knowledge in automation systems, Networks PLC technology
Proven knowledge and understanding of ISA 95 and ISA 88 standards
Proven customer focus experiences and situation al adaptability with both internal and external resources.
Proven experiences in cGxP qualification
Proven experience in support of multi-site projects
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.