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
Manufacturing Execution System Engineer (MES) 100%
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 Manufacturing Execution System (MES).
Main Responsibilities and Accountabilities:
Collaboration with others departments (ex. QA, QC, SAP, Manufacturing, BT or rest of Automation) in the project and later on in routine in order to assure overall coordination of the dependencies and required exchange information for the execution of MES
Responsible and accountable for all project (computerized Systems) related documents (development and testing) such as qualification (DQ, IQ, OQ, PQ), requirements specifications, etc. dealing with the MES
Create prototypes to develop and demonstrate special project features
Develop functional and detailed designs, implement and test complex MES (Simatic IT eBR) solutions using both custom developed software applications and configured products that meet stakeholders' requirements and create technical documentation to a standard required for validated facilities.
Provide the Group Leader with all necessary support and information to ensure that they are fully informed of progress.
Ensure that all Engineering activities are undertaken in accordance with the Company's quality control processes and that the relevant standard is achieved.
Assist and support stakeholders with resolving application problems and installing software upgrades as well as patches for MES systems.
Support and contribute to the development of different Standard Operating Procedures (SOPs), Work Instruction (WI) or Guidelines for qualification and routine activities of the MES
Qualifications & Experience:
Minimum 3 years of relevant experience in MES project execution (requirements analysis, design definition, software development and solutions implementation) in a related process industry such as Biotech/Pharmaceutical, Chemical, Food and Beverage
In-depth working experience in regulated industries; knowledge of cGMP, 21 CFR part11 and validation
Good knowledge and solid experience with MES systems (e.g. Simatic IT eBR, Syncade, Rockwell ProPack Data, Werum PAS-X)
Experience with ERP interfacing (e.g. SAP) or other level 4 (ISA 95) solutions
Following skills will be a strong asset
Working knowledge of SQL Server or Oracle is a plus
Experience of integration with process automation solutions is a plus (e.g. PCS7, DeltaV)
Knowledge of active directory, DNS, IP networks and virtualization is a plus
Languages: English fluent in written and spoken. German is a plus
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 (10 min. from Bienne/Biel).
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.
CSL Behring is committed to provide equal employment opportunity for all.