What are the responsibilities and job description for the Engineer III, Process position at Biogen?
Job Description
In this role you will design, specify, and install new equipment and provide engineering technical support and troubleshooting for processing equipment utilized in oral solid dose manufacturing and oligonucleotide synthesis manufacturing. You will support technical specification of validation protocols, investigate validation deviations, and review final validation reports. You will provide project engineering support as required for new processing equipment installations and modifications to existing site and equipment. You will be able to manage small to medium engineering projects with little direction. The candidate will maintain change control for all validated processing equipment and will investigate deviations related to equipment failures.
Key responsibilities include (but not limited) :
- Assess equipment needs and generates equipment specifications for fabrication or purchase.
- Help implement new manufacturing processes as needed for new products or modifications to existing equipment and processes.
- Investigate process or equipment failures and implements changes to avoid future occurrences.
- Provide troubleshooting support for the manufacturing/process equipment.
- Responsible Engineering (RE) duties which require validation protocol review and approvals and management of change control for the equipment.
- Perform equipment startup; troubleshoots equipment failures; reviews P&ID’s, performs equipment commissioning, reviews maintenance and instrument change requests.
- Able to manage small to medium engineering projects with little direction.
- Work with and provide direction to contractors.
- Participate in multi-function teams to implement change and improve on existing processes.
- Investigate deviations related to equipment failures.
- Author changes to equipment related Standard Operating Procedures
Qualifications
Minimum requirements:
- Bachelor’s degree in engineering or related field
- A minimum of 5 years related experience in a Pharmaceutical environment.
- Practical knowledge and application of cGMP regulations.
- Proficiency in Microsoft Office.
- Excellent oral and written communication skills.
- Ability to respond to trouble calls and provide on-call support.
Preferred skills:
- Experience with Oral Solid Dose manufacturing equipment and chemical processing equipment.
- Comfortable with automated control systems and instrumentation.
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.