Senior Engineer II, Manufacturing Sciences

About This Role:
As a Sr. Engineer II, you will be a pivotal member of the manufacturing team, providing hands-on process and manufacturing sciences expertise to support technology transfers and ongoing clinical and commercial manufacturing programs. Your role is critical in enabling essential manufacturing sciences activities, including new technology transfers, PPQs, and intricate manufacturing investigations, where real-time observation and immediate technical intervention are crucial for successful execution. This position requires a consistent on-site presence to effectively support manufacturing operations, observe process execution, and collaborate directly with cross-functional teams, ensuring alignment and decisive action. You will independently analyze complex technical issues, evaluate data trends, and design studies to enhance process efficiency. In this role, you will lead cross-functional teams and mentor junior employees, ensuring practical and sustainable solutions within the manufacturing environment. Your expertise in parenteral drug product manufacturing, particularly in biologics, will drive strategic initiatives and business process optimization, strengthening accountability and cross-functional alignment at the site.

This role requires working on site for 5 days per week in Athlone.

What You’ll Do:

• Provide hands-on, on-site technical leadership during manufacturing operations, ensuring timely decision-making during live processing.

• Lead rapid assessments and CAPAs for process and product impacts, requiring immediate access to the manufacturing floor and equipment.

• Engage daily on-site with Manufacturing, Quality, and Process Engineering to accurately develop and execute SOPs and batch records.

• Perform real-time data review and trending using tools such as Tableau, Power BI, and SIMCA to proactively mitigate risks.

• Lead or support technology transfers from development to manufacturing facilities, ensuring process and facility fit.

• Own all technical components of transfer activities, partnering closely with Process Engineering and Quality Assurance.

• Identify and lead optimization initiatives, improving productivity and process robustness through on-site observation.

• Drive implementation of improvements directly on the manufacturing floor and monitor effectiveness through in-person engagement.

• Coordinate technical reports for deviations, CAPAs, and technology transfer optimization as a subject-matter expert.

• Support regulatory interactions, including filings and inspections, providing immediate technical support as needed.

Who You Are:
You thrive in dynamic environments and have a passion for hands-on technical leadership. Your ability to analyze complex technical issues and communicate solutions effectively sets you apart. You value collaboration and are adept at engaging with cross-functional teams to drive alignment and decision-making. Your in-depth knowledge of biopharmaceutical manufacturing and process development makes you a trusted resource on the manufacturing floor. You are committed to mentoring and developing junior team members, ensuring the practical execution of strategic initiatives.

Required Skills:

• Bachelor’s Degree in a relevant field.

• Extensive experience in manufacturing sciences/technical development for biologics or parenteral drug products.

• Strong technical leadership capabilities with hands-on experience in manufacturing operations.

• Proficiency in data analysis tools such as Tableau, Power BI, Statistica, and SIMCA.

• Excellent problem-solving skills and the ability to make real-time decisions.

• Experience leading technology transfer projects.

Preferred Skills:

• Experience supporting regulatory activities, including filings, inspections, audits, and interactions with global health authorities.

 

Job Level: Management

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 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.