Job Detail

Job Description

1. Leads BES staff and external contractors in the design, development, integration, installation, verification and qualification of automated processes, equipment, and systems following the guidelines and standards (including ISA S-88, S-95 and GAMP). Provides technical leadership in complex problem-solving and decision-making, collaborates with and influences business stakeholders with a focus on driving and implementing innovative recipe-driven, process automation solutions. Constructively challenges project teams to achieve goals and objectives.

2. Acts as the overall technical project lead for BES process automation systems and solutions, which include DeltaV, Syncade, OSI PI, SynTQ, and Process Analytics. Must also be familiar with and aware of the impact Laboratory Execution, ERP, Asset Management, and other Business Systems have on the operation of the plant.

3. Drives and implements rigorous quality standards for all aspects of the BES delivery from initial concept to final commissioning, validation/qualification and turn-over. Leads the development and execution of engineering documents including URS, Functional Specification, Design specifications, functional tests, Commissioning Plans, and Qualification Protocols. Other responsibilities include developing standards, procedures, training manuals, and other documentation for projects or internal use and providing training to operations and maintenance staff.

4. Supports management in developing and managing Solothurn BES CAPEX budget. Works closely with Program/Project Management & stakeholders to effectively manage process and BES resources to deliver complex projects on time and to budget.

Qualifications

• A B.S. or M.S. degree in one of the following majors or related fields is required: Electrical Engineering, Computer Science, Computer Engineering, Chemical Engineering, and Industrial Engineering.


• Minimum of 10 years of practical experience working as an Automation Engineer delivering to Process Control System requirements in one or more of the following areas is required:  process automation, systems integration, MES, manufacturing data systems, software and equipment commissioning and qualification including computer system validation.


• A minimum of three (5) years of people management or team leadership experience is required. Demonstrated leadership skills with a strong capability to coach, motivate, lead and manage people, teams, process, and projects.


• Working knowledge and experience of relevant industry standards such as ISA S8-88, S-95 and GAMP.


• A minimum of 10 years of experience in the biotech/pharmaceutical industry.

Additional Information

• Responsible for executing Biogen’s Execution Systems strategy and master plan for a recipe driven, fully integrated, and validated biopharmaceutical manufacturing facility in Solothurn (SOL), Switzerland. Must have strong technical experience with implementing manufacturing computer and process automation systems, including but not limited to process control systems (DCS), manufacturing execution systems (MES), and manufacturing data systems (historians, PAT, and analytics).


• Responsible for leading projects for the Solothurn BES department. Allocates resources, assigns priority to tasks and provides guidance for design, implementation, testing and troubleshooting to support the BES systems used for manufacturing operations & support. Projects include new platforms and enhancements through Continuous Improvement & Operational Excellence initiatives. Responsibilities include:

·          Technical lead for the entire lifecycle of projects, including conceptual, basis of design, design, implementation, commissioining, testing and qualification

·          Leads design discussions and decisions

·          Responsible for generation of basis of design, detailed design and design documentation/drawings (URS, System Architectures, specifications, etc.)

·          Coordinates with the Project Managers for project schedule, scope, resources, budget, task status and reporting

·          Builds key relationships with stakeholders, Project Managers and cross functional teams

·          Responsible for resource management of the project team and task assignment

·          Responsible for management of project contractors from the perspective of cost, quality and schedule

·          Tracks delegated tasks to the members of the team

• Responsible for the technical alignment & robust delivery of the BES process automation, MES and data systems.


• Responsible for the technical leadership and oversight of the Solothurn project BES staff & contractors.


• Responsible for incorporation and implementation of Global BES strategies in the Solothurn facility.


• Responsible for ensuring that the integrated recipe solution (involving DCS/MES and interfaces) with Business Systems is fit for purpose, and meets all site and global manufacturing and engineering requirements.