Sr Engineer I, Manufacturing Sciences

About this role

The Senior Engineer I, Manufacturing Sciences is a key technical contributor providing subject matter expertise across end-to-end single-use consumable raw materials, from Drug Substance through Drug Product fill. This role supports the Process Optimization & Technology (PO&T) organization by assessing raw material changes, deviations, CAPAs, and regulatory documentation, while serving as the Subject Matter Expert (SME)  of extractables and leachables (E/L) program assessments.

The position partners closely with suppliers, manufacturing sites, and regulatory teams to ensure materials are fit for use, compliant with evolving global regulations, and capable of supporting both current and future manufacturing needs. This is a hybrid role with on-site presence required during inspections and vendor audits.

What you’ll do

Serve as a technical Subject Matter Expert (SME) for single-use consumable raw materials, supplier capabilities, control strategies, and manufacturing needs across the global manufacturing network

Support development and implementation of raw material control strategies and monitoring technologies to enable incoming material release

Lead continuous improvement initiatives related to raw materials, including technical support for new item requests and supplier audits

Conduct investigations by performing laboratory experiments, gathering supplier data, developing historical trends, and assessing lot usage

Troubleshoot single-use material failures (e.g., filter integrity test failures), perform root cause analyses, and evaluate potential process impacts

Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs), including chemical compatibility, stability, thermal properties, and extractables/leachables impact

Own and support global extractables/leachables studies, ensuring alignment with current global regulatory guidance

Participate in industry forums and external E/L collaborations to advance best practices

Support internal and agency inspections, vendor audits, and regulatory filings related to raw materials and single-use technologies

Who you are

You are a technically curious and analytical engineer who enjoys solving complex manufacturing challenges and collaborating across functions. You work independently, proactively identify improvements, and are comfortable serving as a technical leader within your area of expertise.

Required skills

Bachelor’s degree in relevant scientific or technical fields from an accredited college or university

At minimum 4 years of directly relevant industry or industry-adjacent experience

Proven scientific and analytical skills to evaluate suitability of plastics and single-use technologies across multiple manufacturing modalities

Knowledge of polymeric materials, chemistry, and single-use systems for biopharmaceutical manufacturing

Experience supporting deviations, change controls, CAPAs, and regulatory documentation

Previous experience performing root cause analysis and risk-based technical assessments

Willingness and ability to work on-site more frequently during training periods, critical projects, audits, etc.

Preferred skills

Bachelor’s degree in engineering, chemistry, materials science, or a related technical field from an accredited college or university

Hands-on experience with extractables and leachables studies and regulatory expectations

Familiarity with single-use systems, container closure systems, and supplier change management

Experience supporting regulatory inspections and vendor audits

Prior experience acting as a technical lead or SME within a manufacturing or engineering organization

Participation in industry forums, external collaborations, or technical working groups related to E/L or single-use technologies

Previous experience partnering with external contractors and vendors

Job Level: Professional

Additional Information

The base compensation range for this role is: $98,000.00-$127,000.00

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 Biogen.

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.