Senior Engineer I, Fill Finish Technical Authority

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

• Be a subject matter expert on Fill Finish operations in particular front-end activities: Parts Prep, Compounding and Filling Line operations. Identify and execute on Improvement projects in support of increased productivity, efficiency and operations and ensure that design of equipment, facility and process eliminates potential for contamination.
• Benchmark relevant data/information and translate into measurable improvements in-house; support the sites in troubleshooting / investigation as needed and proactive identification of potential issues to ensure robust operation of the equipment and process. Alignment with site engineering, industrial engineering, manufacturing and other site support functions on requirements and key metrics is key to ensuring cost effective, efficient, and robust operation of equipment and facility.
• Functional activities to support CMO/business development opportunities, front end capital planning and execution of capital projects; deliver engineering solutions driving cost effectiveness, productivity, efficiency, safety, quality, compliance and without delay; ensure that reliability is integrated into the design, construction, and operation of new and existing facilities, equipment, and systems.
• Develop / maintain / improve Fill Finish engineering best practices, standards and specifications.
• Support as required our external CMO partners for Biogen products and processes.

• BS in Chemical or Mechanical Engineering or related process engineering discipline. MS in engineering discipline is strongly preferred but not required
• A minimum of 6 years’ experience in Fill Finish Engineering in Biotech, Pharma or equivalent industry experience
• Detailed knowledge of Fill Finish technical operations including related asset lifecycle management practices; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning / qualification / validation
• Detailed knowledge and experience of Parts Prep, Compounding/Formulation and Fill Line operations (including Isolator technology). Inspections systems (manual and automatic) an advantage.
• Experience in projects design, management (including financial considerations) and execution required
• Detailed knowledge and application of FDA and EMEA regulations
• Good organization, communication, and inter-personal skills are required as well as strong communication and presentation skills
• Ability to influence individuals at both site and global level
• Good understanding of asset lifecycle cycle and management
• Knowledge of other modalities (eg Small Molecule [API/OSD], Finished Goods or Drug Substance) would be an advantage but not required
• Experience in design of equipment and facilities from a contamination control perspective is desirable. This may also include experience with an Architectural & Engineering consultancy company.
• Already established network of technical leaders, peers, and stakeholders in life science industry; Actively participates in industry forums, etc

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.

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.