Role Summary
You are a Senior Process Engineer and subject matter expert within the Drug Product Technical Authority, supporting Finished Goods (FG) and Oral Solid Dosage (OSD) technologies across BiogenβΓΓ΄s global manufacturing network. You will drive technical excellence, ensure equipment and systems compliance, and collaborate with site engineering leads to guide engineering teams in FG and OSD operations. This hybrid role is based in Research Triangle Park, NC.
Responsibilities
- Establish and update engineering standards and best practices for all manufacturing sites, covering both Finished Goods (FG) and Oral Solid Dosage (OSD) 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 inline 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 yearsβΓΓ΄ experience in Engineering/Maintenance in Biotech, Pharma, Medical Device, or similar manufacturing industry.
- Required: Experience in either Finished Goods (device assembly, labelling, packaging) or Oral Solid Dosage environments; 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.
Skills
- Mastery of core engineering principles with ability to apply data-driven analysis to deliver technical solutions.
- Strong communication, presentation, and stakeholder management capabilities.
- Ability to influence at both site and enterprise levels.