Project Engineer - PCS/MES System
Project Engineer - PCS/MES System
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. For one of these products we have already received marketing approval, for the second product we expect global market launch this year. The Lengnau site project generates 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 an experienced
Project Engineer - PCS/MES
The position holder is responsible and accountable for the development, execution and qualification/validation of computerized System, as well as the coordination of Supplier for Software development for MES and Process Control System.
Main Responsibilities and Accountabilities:
- Responsible and accountable for the project management of approved CapEx-projects for computerized Systems for computerized Systems site for PCS and MES including the design and development in order to enable the startup, the commissioning and the validation of the PCS/MES-System at the CSL site Lengnau.
- Coordinate with other project managers (BMS) in the project in order to assure overall coordination of the timelines and resources.
- Liaise with customer groups on the project to ensure delivery according to user requirements, in accordance with quality and safety requirements.
- Leadership and Accountability of the group PCS/MES, Planning of Resources;
Build and lead the PCS/MES System and team 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 expertise for the company's key projects.
- Support the head of Automation in the setting up of the new Quality Management System, including SOPs for qualification and requirement for computerized systems for PCS- and MES-Systems.
- 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/MES).
- 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.
- Contribute to the delivery of the company strategy as well as supporting the financial CapEx budgeting process for MES and PCS.
- 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/MES-System.
Qualifications / Experience:
- Degree (Bachelor, Master or long experience in an equivalent position) automation-, electro- or electronic-Engineer (Dipl. Ing. or M.Sc. or B.Sc. or equivalent).
- Several years of successful project management and leadership experience on mid-sized and major projects for computerized systems with high complexity and multiple interfaces with BMS in the chemical, biotech- or pharmaceutical industry.
- Proven project management skills including contract management and controlling.
- Proven experiences and knowledge in automation systems, Networks and PLC technology and MES
- Proven leadership experiences for the management of internal and external resources.
- Proven experience in cGxP and qualification.
- Proven experience in support of multi-site projects and startup of new facility an asset.
- Very good command of German and English.
Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?
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 HR Operations, at +41 31 344 12 14.
Offices will be in Stöckacker, Bern, and later in Lengnau.
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