Senior Process Engineer- Oral Solid Dose and Finished Goods

Senior Process Engineer- Oral Solid Dose and Finished Goods at Biogen summary:

Senior Process Engineer responsible for technical leadership and subject matter expertise for Oral Solid Dosage (OSD) and Finished Goods (FG) manufacturing, supporting device assembly, labeling, packaging, blistering, and bottling operations across a global network. Duties include establishing engineering standards, leading technical assessments and capital projects, supporting tech transfers, driving continuous improvement, ensuring regulatory compliance, and guiding site engineering teams. Role requires a BS in engineering, minimum 4 years in biotech/pharma/medical device manufacturing engineering or maintenance, strong communication and data-driven problem-solving skills, and experience with OSD and/or FG operations.

About This Role

As a Senior Process Engineer, you will be a key contributor and subject matter expert within the Drug Product Technical Authority supporting Oral Solid Dosage (OSD) & Finished Goods (FG) technologies responsible for driving technical excellence across Biogen’s global manufacturing network. This pivotal role ensures the optimal performance, availability, and compliance of equipment and systems supporting device assembly, labelling, packaging, and oral solid dosage drug product operations. These areas cover both large molecule injectables and devices as well as small molecule, which includes blistering and bottling operations. You will collaborate closely with site engineering leads, providing guidance and oversight to engineering teams, and driving modality development, enhancement, and governance. Your expertise will optimize operations and deliver value to the business, maintaining a strong position within Biogen’s global framework.

This is a hybrid role to be based at our offices in Research Triangle Park, NC.

What You’ll Do

• 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 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.

Who You Are

You are an experienced engineer with a solid background in process engineering, experienced in both Oral Solid Dosage and Finished Goods manufacturing. You are a strategic thinker, equipped to serve as a technical SME, and thrive on data-driven analysis to deliver innovative technical solutions.

Qualifications

Required Skills:

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

• Minimum 4 years’ experience in Engineering/Maintenance in Biotech, Pharma, Medical Device, or similar manufacturing industry.

• Experience in either Oral Solid Dosage or Finished Goods (device assembly, labelling, packaging). Highly preferred to have experience in both.

• Effective at influencing both site and enterprise levels.

• Strong communication, presentation, and technical skills.

• Expertise in core engineering principles.

Preferred Skills:

• Master’s in Engineering.

• Engineering & Architectural firm (A+E) experience in the study and design of processes for FG and/or OSD modalities.

Job Level: Professional

Additional Information

The base compensation range for this role is: $91,000.00-$118,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Keywords:

process engineer, oral solid dosage, finished goods, pharmaceutical manufacturing, technical authority, capital projects, tech transfer, continuous improvement, regulatory compliance