DSP Manufacturing Sciences Engineer III
vor 4 Wochen
About This Role
Join our team as a critical technical expert for Downstream process transfer and process sciences at our Solothurn Drug Substance manufacturing facility. This position provides key technical subject matter expertise to Downstream process transfer & process sciences activities to support technology transfer & operations at the Solothurn Drug Substance manufacturing facility. Assignments may vary per overall MS team and site requirements.
You will coordinate /participate in cross-functional process transfer sub-teams for new product introduction, PPQ or restart campaigns. Provide technical support to operations by leading process related investigations, impact assessments and CAPAs.
In addition, you'll design and execute process science lab studies to support facility fit, campaigns, investigations, and innovation. Perform data analysis to support process science studies, process consistency and improvements. Author and review technical protocols & reports for process validation, investigations, process sciences studies and regulatory commitments.
What You'll Do
- Coordinate cross-functional process transfer sub-teams (Operations, Development, Process and Automation Engineering, QA and QC) for new product introduction, PPQ or restart campaigns (e.g. PFD creation, protocol & report authoring, change management) week.
- Provide technical support to operations by leading process related investigations, performing impact assessments and leading the implementation of CAPAs. Lead technical projects towards improved facility capabilities, process understanding, robustness and efficiency.
- Design and execute process science lab studies to support facility fit, campaigns, investigations, and innovation. Perform data analysis to support process science studies, process consistency and improvements. Support day-to-day lab operations and execute activities in compliance with lab and EHS directives.
- Author and review technical protocols & reports for process validation, investigations, process sciences studies and regulatory commitments. Ensure timely, clear communication and escalation of results
Who You Are
As an individual, you have strong experience in monitors processes, identifying areas for improvement, and implements changes as needed. You have a deep understanding of process descriptions, process control strategies, and operational quality concepts and you are a strong communicator.
- B.Sc. or M.Sc. degree in Chemical or Bioprocess Engineering, Biochemistry, Chemistry, Biology or closely related discipline (B.Sc. with minimum 4 years of experience in upstream process, or M.Sc. with minimum 2 years experience in upstream process).
- Deeply understands process descriptions and process control strategies and masters process technology processes.
- Understands operational quality concepts and masters usage of quality management systems.
- Knowledgeable regarding manufacturing execution systems (Syncade and Delta V)
- Understands extended biotechnology processing – details of major unit operations and microbial control concepts.
- Actively manages their individual training plan and ensures that they are trained on relevant procedures prior to performing for cGMP operations. Supports the training of co-workers.
- Fully understands cGMP requirements and applies these requirements to all situations.
- Excellent investigational and writing skills.
- Understands statistical tools.
- English B1 as a minimum.
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
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