Engineer III, Manufacturing at Biogen in Research Triangle Park, North Carolina

Job Description:

Job Description

About This Role

The Engineer III Manufacturing designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets.  Develops validation protocols, oversees validation testing and drafts final reports.  Provides project engineering as required for new processing equipment installations and modifications to existing equipment.  

What You'll Do

• Support Manufacturing operations by troubleshooting issues and identifying equipment system improvements. Update standards, drawings and specifications as necessary.


• Identify and lead equipment related projects, including technology transfers, capital projects, and modifications. Complete project management tracking of deliverables for metrics & reporting.  Provide input & guidance to Tech Transfer and project / area efforts, provide technical evaluations of validation requirements for core change controls & associated action plans.  


• Author sections of Validation-related reports & project plans, approve Trackwise-generated workflows (deviations, global change controls) for equipment / automation-related changes, review automation protocols, & attend related meetings. 


• Coordinate Equipment/Cleaning Validation Protocols (development, training, management, tracking) - includes time spent on production floor. Specifically design & develop validation protocols, provide expertise to associated equipment & automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required. 

Who You Are

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.

Qualifications

• Bachelor's degree in engineering or other highly technical discipline 


• Practical knowledge and application of GMP and EMA regulations. 


• 2-4 years of experience in manufacturing, preferably in a pharmaceutical or biotech environment.


• Competency in Process Controls and Distributed Controls Systems, MS Word, MS Excel, MS Power Point and MS Project. 


• Excellent oral and written communication skills. 


• Ability to work rotating shifts, extended shifts (including weekends) and on call as needed. 


• Experience with either Fill Finish, Isolator (Bausch and Stroebel) and Lyophilizer technologies preferred.

Additional Information

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.

 

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