This Engineer is responsible for the operation, maintenance and expansion of the manufacturing data systems for Biogen’s Next Generation Manufacturing Execution System supporting Pharmaceutical Operations and Technology (PO&T) in Solothurn, Switzerland.
Configures system modifications to meet site operational and project needs, while maintaining all system related lifecycle artifacts.
Ensures system robustness through execution of routine monitoring and implementation of metrics to evaluate system performance. Works with stakeholders and users to ensure that service objectives are met.
Provides input and recommendations regarding business continuance issues and improvements to operating systems and processes.
Provides guidance, technical advice, planning and project management both within the group and with outside consultants and vendors.
Provides training for onsite Users / Engineers in Automation technologies and applications.
Provides after hours (on call) support as needed on a regular rotation.
Ensures compliance with corporate standards and policies, including code of conduct, safety, GxP compliance, data security, and the software development lifecycle.
Qualifications
Bachelor’s Degree in a relevant Engineering or equivalent IT discipline with a minimum of 8+ years of related industry experience in a pharmaceutical, Biotechnology, drug development or equivalent environment and at least 4+ years of experience with OSIsoft PI implementation.
Direct experience designing, building, deploying and supporting manufacturing data systems in a regulated large-scale pharmaceutical manufacturing environment.
Solid understanding of the OSIsoft PI system architecture with 4 year plus experience in PI System implementations.
Experience designing and implementing highly reliable and large-scale PI systems with HA collectives and redundant nodes.
Experience installing, configuring, validating, and tuning PI Server and interfaces.
Experience implementing analytic solutions with PI Asset Framework, Event Frames, Analytics and Notifications.
Experience installing and tailoring client software including PI Vision, ProcessBook, DataLink, RTReports and PI Vision.
Experience integrating with MES and DCS-based control systems, building management systems, and laboratory equipment.
Experience in a GMP regulatory environment.
Solid understanding of Windows OS, networking, and system security fundamentals.
Experience with Infobatch, Simca, SynTQ and Topview is a plus.
Additional Information
This Engineer is responsible for the development, implementation and operational support of the manufacturing data systems for Biogen’s Next Generation Manufacturing Execution System supporting Pharmaceutical Operations and Technology (PO&T).
