Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Sr. Engineer I, Automation (Syncade)
Works closely together with the BES manager and, if applicable, project manager to ensure deliverables are ready in time for the different milestones throughout the project and operational state of the facility. Aligns and reviews deliverables from the different Syncade work areas/packages. Works in close collaboration with the system Process Owners and Manufacturing staff to ensure the overall recipe design and implementation meets Engineering and manufacturing requirements for the operation of the plant.
Writes, reviews and approves MES documentation. Completes tasks related to lifecycle and project documents, procedures and work instructions as needed.
Participates in the definition of the BES validation strategy together with BES CSV and SOL Quality representatives. Collaborates with other disciplines to ensure overall coordination of the tasks and consistency in execution strategies. Supports the Validation of the systems, with appropriate change controls.
Performs configuration on the various Syncade systems (VAL and PROD) with appropriate change controls, and troubleshoots issues encountered during testing or operations. Seeks opportunities for optimization of the design, programming and testing activities within the BES scope. Responsible for change controls per Biogen/SOL procedures.
Performs system maintenance tasks and user management activities.
Interfaces with customer groups on the project to ensure we are designing, executing, and delivering to in accordance to Global Engineering Procedures, including Quality, Facilities, MEF, MFG, and EHS. This will include building strong relationships with the customer base and helping them set the proper expectations for project delivery.
The incumbent is required to have minimum a Bachelor of Science degree in Automation, Electrical, Chemical, Mechanical Engineering or similar.
A minimum of 8 years related experience and/or training; or an equivalent combination of education and experience.
A minimum of 5 years in a large scale pharmaceutical manufacutirng environment, with direct experience in support of manufacturing operations.
Fluency in English is required, any additional language is an asset.
Supporting the design and development of the Syncade MES system at the new Large Scale Manufacturing facility located at the Solothurn, Switzerland campus.
Scope includes supporting the development of the Syncade systems to align with the Next Generation Automation approach of controlling the process and information systems within the Next Generation Manufacturing Operation. This scope will also include aligning the scope definition of the required hardware coordinated with the Manufacturing group, development of the software and system coordinated with the required project schedule to enable commissioning and validation of the process systems to meet the overall project schedule. Further to coordinate interfaces with the DCS DeltaV, Data Historian (PI), Building Management System (BMS), Central Alarm Management System and the Manufacturing Control Network (MCN).
Responsible for the technical alignment of Syncade MES systems in the NGM project reporting into Sr Manager, Automation with overall Automation project responsibility.
Responsible for the delivery of a technical robust solution.
Responisble for incorpation and implementation of Global BES strategies in the NGM facility.
Responsible for ensuring the integrated recipe solution (involving DCS/MES and interfaces) with Business Systesms is fit for purpose and meets all site and global manufactirng and engineering requirements.