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 youll 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

• Bachelors 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

• Bachelors 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

Additional Information

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 $10000 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 onto 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.