Manufacturing Engineer III – Solid Dose Manufacturing

Biogen•Research Triangle Park, NC

1d•Onsite

About The Position

As a Manufacturing Engineer III, you will serve as a key technical resource supporting manufacturing equipment within our production areas, with a focus on solid dose (OSD/ASO) operations. This role plays a critical part in maintaining reliable manufacturing processes, improving equipment performance, and driving continuous improvement initiatives. You will partner closely with manufacturing, maintenance, and cross-functional teams to troubleshoot issues, lead equipment-related projects, and ensure successful validation and implementation of new or modified systems.

Requirements

Bachelor's and/or master’s degree in engineering from an accredited college or university
2+ years of experience supporting manufacturing equipment
Experience with some or all the below in a cGMP environment: Troubleshooting and root cause analysis
Continuous improvement methodologies and equipment optimization
Hands-on mechanical aptitude with manufacturing equipment
Experience supporting CQV activities, including protocol development and execution
Strong ownership mindset with demonstrated initiative and accountability

Nice To Haves

Experience with some or all the manufacturing equipment below: Solid dose manufacturing (OSD, OSM, or ASOS)
Parenteral fill (PF) operations
Hands-on experience with equipment such as: Chromatography skids or columns
Tablet presses
Encapsulation machines
Isolators

Responsibilities

Support manufacturing operations by troubleshooting equipment issues and driving root cause analysis, implementing sustainable solutions to improve uptime and reliability
Serve as the equipment SME for assigned manufacturing systems, providing hands-on technical support and guidance
Lead and support continuous improvement (CI) initiatives to optimize equipment and manufacturing performance
Design, specify, and support installation or modification of manufacturing equipment and systems
Develop, execute, and support CQV (Commissioning, Qualification, and Validation) activities including protocol authoring, execution, and reporting
Partner with process and maintenance teams to resolve equipment issues and enhance overall manufacturing capability
Lead or contribute to equipment-related projects, including capital projects, tech transfers, and system upgrades
Support onboarding, training, and drawing/documentation management for equipment and systems
Participate in investigations (deviations, CAPAs) and change controls related to equipment and process improvements
Provide on-call support as needed, with a focus on parenteral fill (PF) or manufacturing support areas

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