Manufacturing Process Specialist

Biogen•Research Triangle Park, NC

1d•Onsite

About The Position

In this Parenteral Filling Manufacturing Process Specialist 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.

Requirements

Bachelor’s degree (Life Sciences or Engineering ) preferred, with 0-1 years of transferrable experience
Associates Degree or Bioworks Certificate and 2 years of transferrable Experience
High School Diploma (or Equivalent) 4 years of transferrable experience
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

Nice To Haves

Prior experience supporting Investigations within manufacturing operations
Prior experience in manufacturing – drug product operations
Understanding of business processes and roles of cross-functional groups supporting manufacturing operations
Robust understanding of quality and cGMP principles
Fundamental knowledge of change control in cGMP environment

Responsibilities

Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution –participate in projects (simple to moderately complex in nature), 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, investigations, and planned exceptions

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation