Sr. Manufacturing Specialist II, MFG Tech Ops
Biogen
Full-time
On-site
Triangle, NC
$109,000 - $146,000 USD yearly
Operations
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Role Summary
Sr. Manufacturing Specialist II, MFG Tech Ops – In this 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.
Responsibilities
- 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.
- 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.
Qualifications
- Bachelor’s degree (Life Sciences or Engineering) preferred, with 7 years of transferrable experience.
- Associates degree or Bioworks Certificate and 9 years of transferrable experience.
- High School Diploma (or Equivalent) and 11 years of transferrable experience.
- Prior experience in manufacturing – Drug Product/ Parenteral Filling
- Project Management skills
- Robust understanding of quality and cGMP principles.
- Fundamental knowledge of change control in cGMP environment.
Preferred Skills
- Understanding of business processes and roles of cross-functional groups supporting manufacturing operations.
- Intermediate to advanced skills in Microsoft Office and computer-based quality systems.
- Intermediate to advanced level of technical writing skill.
- Ability to interpret manufacturing process design documentation.
- Excellent oral and written communication skills.
- Experience in Continuous Improvement initiatives.