Senior Process Engineer- Oral Solid Dose and Finished Goods

Role Summary

Senior Process Engineer and subject matter expert supporting Oral Solid Dosage (OSD) and Finished Goods (FG) technologies within Biogen’s Drug Product Technical Authority. Responsible for driving technical excellence across the global manufacturing network, ensuring optimal performance, availability, and compliance of equipment and systems supporting device assembly, labeling, packaging, and oral solid dosage drug product operations. Hybrid role based in Research Triangle Park, NC.

Responsibilities

• Establish and update engineering standards and best practices for all manufacturing sites, covering both Oral Solid Dosage (OSD) and Finished Goods (FG) operations.
• Lead technical assessments, Facility Fit Feasibility Studies and process improvement initiatives for informed decision-making by senior leadership.
• Integrate engineering considerations into new projects and participate in capital planning for both Finished Goods and Oral Solid Dosage.
• Support the execution of Capital projects in line with the OSD and FG modality requirements and Capital Project Management processes. Support tech transfers for OSD as necessary from an engineering & facilities standpoint.
• Provide direction and support to site engineering teams, ensuring program adherence and technical excellence in both domains.
• Implement continuous improvement strategies for equipment and system performance.
• Investigate innovative technical, equipment and process solutions, benchmark against industry best practice and alignment.
• Support development of business cases requiring capital investment and participate in capital planning for related project opportunities.
• Engage with external vendors and industry experts for insights into new and innovative technologies relevant to both Finished Goods and Oral Solid Dosage manufacturing.
• Employ a data-centric approach to engineering for both Finished Goods and Oral Solid Dosage assets.
• Ensure regulatory compliance, adherence to standards, and alignment with company policies for all engineering activities.

Qualifications

• Required: BS in engineering (mechanical, chemical, electrical, industrial) or related discipline.
• Required: Minimum 4 years’ experience in Engineering/Maintenance in Biotech, Pharma, Medical Device, or similar manufacturing industry.
• Required: Experience in either Oral Solid Dosage or Finished Goods (device assembly, labeling, packaging). Highly preferred to have experience in both.
• Required: Effective at influencing both site and enterprise levels.
• Required: Strong communication, presentation, and technical skills.
• Required: Expertise in core engineering principles.
• Preferred: Master’s in Engineering.
• Preferred: Engineering & Architectural firm (A+E) experience in the study and design of processes for FG and/or OSD modalities.

Education

• BS in engineering (mechanical, chemical, electrical, industrial) or related discipline.