About This Role:As a Senior Manufacturing Engineer I, you will provide engineering support for fill-finish manufacturing operations by designing, installing, and optimizing process equipment to ensure reliable, efficient, and compliant production processes. You will lead troubleshooting activities, support equipment lifecycle management, and drive continuous improvement initiatives across aseptic filling, inspection, packaging, and associated manufacturing assets.
In this role, you will be responsible for developing and executing validation protocols, overseeing qualification and validation activities, and preparing final technical documentation.
You will manage small to medium-sized engineering projects, including the installation of new process equipment and modifications to existing systems, while coordinating contractors and collaborating with cross-functional teams to successfully implement process improvements and operational changes.
What You'll Do:- Support manufacturing operations by troubleshooting equipment and process issues, identifying system improvements, and updating engineering standards, drawings, and technical specifications.
- Lead and support equipment-related projects, including technology transfers, capital investments, equipment upgrades, and process modifications.
- Provide engineering support for fill-finish manufacturing processes and equipment, including aseptic filling, component preparation, visual inspection, container closure systems.
- Manage project deliverables, timelines, metrics, and reporting to ensure successful project execution and compliance.
- Provide technical input for technology transfer activities, change controls, validation requirements, and associated action plans.
- Author and review validation documentation, project plans, and technical reports supporting manufacturing and engineering activities.
- Approve equipment and automation-related changes through TrackWise workflows, including deviations and change controls.
- Coordinate equipment and cleaning validation activities, including protocol development, training, execution, tracking, and documentation.
- Design and execute validation protocols while providing technical expertise for equipment and automation design, installation, and modification projects.
- Support Factory Acceptance Testing (FAT), equipment commissioning, startup activities, and qualification efforts.
- Collaborate with cross-functional teams to implement process improvements, drive operational excellence, and support manufacturing performance.
- Maintain training compliance, track assigned goals and development objectives, and ensure completion of required quality and compliance activities.
- Perform additional engineering and operational duties as required to support business and manufacturing needs.
Who You Are:You are an experienced manufacturing engineering professional with a strong ability to manage equipment, process, and project activities in a regulated production environment. You are confident leading investigations into equipment and process issues, identifying root causes, and driving effective corrective actions. Comfortable working independently, you collaborate closely with cross-functional teams, contractors, and external partners to deliver projects, technology transfers, and operational improvements. You bring strong technical and organizational skills, with experience managing compliance-related activities, meeting project milestones, and mentoring junior engineers to support team development and business success.
Required Qualifications:- Bachelor's degree in Engineering or a related technical discipline.
- Proven experience within a pharmaceutical, biotechnology, or highly regulated manufacturing environment.
- Demonstrated hands-on engineering experience supporting an aseptic fill line in a GMP-regulated fill-finish manufacturing environment, including filling equipment, associated process systems, troubleshooting, qualification, and operational support.
- Strong understanding of GMP requirements and applicable regulatory standards.
- Working knowledge of Process Control Systems (PCS) and Distributed Control Systems (DCS).
- Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Project.
- Strong problem-solving and analytical skills, with the ability to investigate complex equipment and process issues.
- Solid understanding of manufacturing processes, engineering systems, equipment lifecycle management, and validation activities.
- Excellent verbal and written communication skills, with the ability to collaborate effectively across cross-functional teams.
- Demonstrated ability to manage multiple priorities, meet deadlines, and deliver results in a fast-paced manufacturing environment.
- Sound engineering judgment and the ability to identify and resolve deviations from established processes and standards.
- Flexible and adaptable, with the ability to support extended hours when required to meet business and operational needs.
Job Level: Professional
Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
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 Biogen.
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.
