Posted in Engineering 30+ days ago.
Type: Full Time
Job Description
The Fill Finish Engineering Technical Authority function (as part of the Global Engineering and Facilities function) is looking to hire an individual contributor who is accountable for subject matter expertise in fill finish engineering and technical operations as related to all Parenteral products manufactured. At Biogen, Subject Matter Expertise is demonstrated by possessing a comprehensive understanding of the complete asset lifecycle, which includes performance, design, install, CQV, operation, maintenance, and reliability requirements. This role and team effectively contribute and add value to all stages of the asset's lifespan, ensuring standards, specifications, strategic approach to manage the lifecycle of the asset ensure optimal performance, efficiency, and longevity.
This SME will have a fill finish, aseptic and engineering body of experience, a passion for innovation, and the ability to build strong partnerships at all levels across the enterprise. Parts Prep, Compounding and Fill Line (including Isolator technology) is the primary focus of this role but overall support for Fill Finish end to end process is required.
This is a hybrid role to be based at our site in RTP, NC.
What You'll Do
Qualifications
Who You Are
This individual should have a detailed understanding of Fill Finish manufacturing processes and equipment and a proven ability to apply his/her expertise to identify areas of opportunity and provide solutions for improvement . He/she should have experience working on projects, specification and qualification of new or existing equipment within Fill Finish processes, inline with current regulations and have demonstrated an ability to work collaboratively with cross-functional teams to deliver results. Demonstrated her/his ability to provide detailed scope of projects and support the process to obtain 'buy-in' from leaders and decision makers at senior and executive level. Ideally has experience in contamination control measures as related to engineering solutions and experience in developing and maintaining engineering specification documents.
Additional Information
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.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
PDN-9b8f0c28-22f9-4598-a91f-f87c696d5a8f
Biogen |
Biogen |
Biogen |