Job Information
Biogen Engineer II, Manufacturing in Research Triangle Park, North Carolina
About This Role
The Manufacturing Engineer II designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification. The incumbent would support technology transfer of new processes into the facility, provide project engineering support as required for new process equipment installations and modifications to existing process equipment and have the ability to manage small engineering projects with little direction. In addition, they would develop validation protocols, oversee validation testing and final report approvals. This role will work with and provide some direction to contractors and participate in multi-function teams to implement change and improvements on existing processes.
What You'll Do
Responsible for supporting manufacturing operations by troubleshooting process equipment system issues and identifying improvements. Update preventative maintenance job plans, equipment standards, drawings and specifications as necessary.
Identify and support process equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and area efforts, provide evaluations of process equipment including validation requirements for change controls and associated action plans.
Authors and approves GMP generated workflows (change controls, deviations, CAPAs) for equipment/automation related changes, impact assessments, review automation protocols, and attend related meetings.
Coordinate process equipment/cleaning validation protocols (development, management, tracking) including time spent on manufacturing floor. Specifically design and develop validation protocols, provide support for associated equipment and automation design / modifications, equipment startup, & commissioning efforts, as required.
Who You Are
You are a process equipment engineer who likes to troubleshoot and investigate improvements to increase site operations and passionate about learning new technologies and working in a cross-functional environment. You are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Manufacturing Engineering organization, your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.
Bachelor's degree in engineering.
0-2 years of experience in manufacturing, engineering or validation, preferably in a biologics drug substance environment.
Experience with bioreactor, centrifugation, chromatography or viral/ultra-filtration unit operations preferred
Practical knowledge and application of GMP regulations and guidelines (ISPE, USP, PIC/S, Annex, ICH, etc.).
Competency in DeltaV, MS Word, MS Excel, MS Power Point and MS Project.
Excellent organization, time management, oral and written communication skills.
Ability to work on-site
Ability to work rotating shifts/on-call, extended coverage support and weekends as needed
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 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.