Sr Process Engineer I / II

Engineering        ·        Research Triangle Park, NC    ·         Full time 

• Research Triangle Park, NC
• Full-time
• Department: Engineering
• Region: US

Job Description

About This Role

With a state-of-the-art facility in biologic manufacturing processes, talented engineers are extremely valuable to our site, responsible for the equipment and systems that create products for our patients. 

In this role, you will perform equipment support activities and provide engineering technical support primarily in the manufacturing area. You will manage small engineering projects and provide engineering support to new product Tech Transfer activities and investigations. You will participate in cross-functional teams to implement change, improve existing processes, and support the design, specification and installation of new equipment and modifications to existing equipment.  As a senior engineer, you aid in the development of junior process engineers, and you are able to manage medium to large engineering projects with little direction. 

What You’ll Do

• Identify and lead equipment related projects, including technology transfers, capital projects, and modifications.
• Direct and support design, specification and installation of new equipment and modifications to existing equipment
• Develop and support equipment commissioning and qualification (validation) activities.
• Troubleshoot equipment systems and support associated automation system troubleshooting efforts.
• Manage and track completion timelines for compliance tasks (change controls, deviation investigations, corrective & preventive actions).
• Maintain personal training, goal development / completion, compliance workflow tracking, & progress tracking.
• Manage and provide direction to contractors and junior staff
• Lead multi-function teams to implement change and improve on existing processes.
• Communicate with internal and external contacts across multiple organizations including presentation of initiatives to senior management.

Who You Are

You are an experienced process engineer who likes to troubleshoot and investigate improvements to increase site operations. You love learning new technologies and working in a cross-functional environment. 

Qualifications

• Practical knowledge and application of cGMPs.
• Ability to work on site.
• Available to work on call.
• Assignments are complex in nature where ability to recognize deviation from accepted practice is required. Judgment is required in resolving problems & making routine recommendations. 

Process Engineer I:

• Bachelor’s Degree in Engineering or related field required
• 4-6 years process engineering experience in a regulated manufacturing environment required.

Process Engineer II:

• Bachelor’s Degree in Engineering or related field required
• Minimum 6 years process engineering experience in a regulated manufacturing environment required.

Preferred Skills

• Biotechnology or pharmaceutical experience.
• Experience with biologics drug substance manufacturing.
• Preferred competency in Delta V or other DCS.

Additional Information

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.

Please click here to apply.