The coordinator V is responsible for supporting / enabling manufacturing activities in regard to Compliance, Documentation, Recipe driven operations, Changeover, Tech transfer, and or Training for day-to-day activity.

In addition, the Coordinator V is in charge to represent Manufacturing by participating in intra, cross site alignments and cross functional projects related to process improvements and efficiency

Thorough understanding of the manufacturing processes and ability to accurately review GMP documentation including validation protocols is required. 

This person will also manage and monitor Minor deviations and Incidents from the floor and will work closely with the Manufacturing Technical Operations.

Accountability Description

• Supports in generating area assessment and performs root cause investigations in Minor Deviations / Incidents / Action Alert / Environment Monitoring excursions and Remedial Action Reports
• Area of expertise: Upstream or Downstream
• Acts as Subject Matter Expert on manufacturing equipment and processes within limited scope assisted by senior team members. Participates in changeover and tech transfer activities as needed. Authors related technical instructions and records including Resource Group / Resource Text, Procedures, work instructions and forms
• Responsible for supporting major deviations, CAPAs, and GCCs closure as needed
• Coordinates CQV activities, ensuring proper and timely execution of validation protocol.
• Works collaboratively as part of either an upstream processing or downstream processing team to provide support and troubleshooting, identifies continuous improvement projects continually invest in efficiency gains to drive down cost of goods, and oversee their implementation in close collaboration with Manufacturing Technical Operations and process Engineering.
• Acts as an SME during internal/ external audits

• Extensive experience of direct experience working in a GMP environment preferably in Biologics manufacturing.
• High school diploma or equivalent as a minimum. Bachelor’s degree or higher preferred. Other combinations of education and experience can be considered.
• Ability to interact with a cross functional team effectively within organization
• Highly detailed oriented with excellent documentation skills
• Solid knowledge of business and manufacturing processes to support manufacturing operations
• Solid knowledge of Manufacturing Systems (Delta V, Syncade, Simca, PI, Oracle, Trackwise...)
• Solid understanding of the basic QA and cGMP principles
• Fundamental level of technical writing skills, Intermediate to advanced skills in Microsoft Office

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts