Senior Fill Finish Process Engineer

About This Role: As the Senior Engineer I in the Global Engineering and Facilities division, you will be the Fill Finish Engineering SME, playing a pivotal role in the lifecycle management of Parenteral products across Biogen's multi-site operations. Your expertise in formulation, fill, and finish processes will be central to ensuring the excellence and integrity of our manufacturing systems. You will be responsible for spearheading innovation, championing technical operations, and fostering robust cross-functional partnerships to enhance productivity and ensure compliance. This position will not only influence our internal practices but will also extend support to our external contract manufacturing organizations (CMOs), ensuring Biogen's standards are upheld globally.

What You’ll Do:

• Provide subject matter expertise on Fill Finish operations, especially in Parts Prep, Compounding, and Filling Line operations.
• Drive improvement projects for productivity and efficiency, minimizing contamination risks.
• Translate benchmark data into actionable in-house improvements, supporting sites with proactive troubleshooting as necessary.
• Align with site engineering, manufacturing, and support functions to achieve cost-effective, efficient operations through improvement initiatives and Capital projects.
• Develop and maintain best practices, standards, and specifications for Fill Finish engineering.
• Participate in the planning and execution of capital projects, integrating reliability into facility and equipment design.

Who You Are: You are a visionary engineer with a passion for innovation in the biotech and pharma space. With a robust background in fill finish processes, you thrive in strategic roles that influence long-term planning over daily operations. You are eager to expand your impact on a global / multi-site scale.

This is a hybrid role to be based at our site in RTP, NC. #LI-CC1

Requirements

Required Skills:

• BS in Chemical or Mechanical Engineering or related engineering discipline
• 4+ years of Fill Finish Engineering experience in the biotech or pharmaceutical industry.
• Proficient in all aspects of Fill Finish technical operations and asset lifecycle management.
• In-depth knowledge of Parts Prep, Compounding, and Fill Line operations, including Isolator technology.
• Demonstrated project management skills, including financial acumen.
• Familiarity with FDA and EMEA regulations.
• Excellent organizational, communication, and interpersonal skills.
• Proven ability to influence at site and global levels.
• Strong understanding of asset lifecycle management.

Preferred Skills:

• MS in Chemical or Mechanical Engineering or related engineering discipline
• Established network within the life science industry and active industry forum participation.
• Experience in contamination control and developing engineering specifications