Manufacturing Specialist III, MFG Tech Ops

Job Description

About this Role

In this Small Scale Manufacturing (SSM) Manufacturing Specialist III role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

What You’ll Do

• Author manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records and deliver on key stakeholder requirements with a minor degree of supervision.
• Project management and project execution – lead or participate in projects, facilitating timely execution.
• Utilizes technical experience, judgement, and precedent to identify, troubleshoot, and resolve straightforward technical and operational problems that arise.
• Proactively identifies continuous improvement opportunities, shares knowledge cross functionally, and drives site implementation.
• Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
•  Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
• Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions
• This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.

Who You Are:

If you are a highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team!  This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives

Qualifications

About this Role

In this Small Scale Manufacturing (SSM) Manufacturing Specialist III role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

What You’ll Do

• Author manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records and deliver on key stakeholder requirements with a minor degree of supervision.
• Project management and project execution – lead or participate in projects, facilitating timely execution.
• Utilizes technical experience, judgement, and precedent to identify, troubleshoot, and resolve straightforward technical and operational problems that arise.
• Proactively identifies continuous improvement opportunities, shares knowledge cross functionally, and drives site implementation.
• Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
•  Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
• Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions
• This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.

Who You Are:

If you are a highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team!  This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives

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 le