Senior Engineer I, Manufacturing Sciences

About This Role:
As a Senior Engineer I you will play a pivotal role in providing hands-on process and manufacturing sciences expertise to support technology transfers and ongoing clinical and commercial manufacturing programs. This position is integral to enabling critical manufacturing sciences activities including new technology transfers process performance qualifications (PPQs) and complex manufacturing investigations. Your consistent on-site presence will be essential for effective support of manufacturing operations allowing for direct collaboration with manufacturing engineering quality and partner functions. By observing process execution in real time you will facilitate immediate technical intervention and accurate problem definition. Your leadership will be crucial in driving strategic initiatives and business process optimization ensuring practical executable and sustainable solutions within the manufacturing environment. Focused on parenteral drug product manufacturing this role is crucial for the successful execution of manufacturing strategies and strengthening cross-functional alignment.

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

What Youll Do:

• Provide hands-on on-site technical leadership during manufacturing operations making timely decisions during live processing for issue resolution.

• Lead rapid process and product impact assessments and corrective and preventive actions (CAPAs) requiring immediate access to the manufacturing floor.

• Engage daily with Manufacturing Quality and Process Engineering to ensure accurate development and execution of SOPs and batch records.

• Perform real-time manufacturing campaign data review and trending using tools such as Tableau Power BI Statistica and SIMCA.

• Support technology transfers from development and external partners to manufacturing facilities assessing process and facility fit.

• Partner closely on-site with various teams to ensure rapid alignment and execution during active transfers.

• Work alongside manufacturing and engineering teams to develop tests ensuring process execution as intended.

• Identify optimization initiatives to improve productivity and process robustness through on-site observation.

• Coordinate technical reports and data supporting deviations CAPAs and technology transfer optimization.

• Serve as an on-site subject-matter expert in biopharmaceutical manufacturing and/or process development.

• Support regulatory filings requests for technical queries (RTQs) inspections and audits as needed.

Who You Are:
You possess a keen ability to independently analyze complex technical issues and are adept at evaluating manufacturing data to identify improvement opportunities. Your skills in designing executing and communicating studies are exceptional and you thrive in in-person engagements with cross-functional teams. Your strong presence on the manufacturing floor ensures accurate translation of process knowledge into execution and your leadership style strengthens accountability and alignment across functions. You are committed to staying on the cutting edge of biopharmaceutical manufacturing bringing your expertise and passion for process optimization to every project.

Required Skills:

• Bachelors Degree in a relevant field.

• Strong technical expertise in manufacturing sciences/technical development for biologics or other parenteral drug products.

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

• Excellent communication and collaboration skills to engage with cross-functional teams.

Preferred Skills:

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

• Proven track record in strategic initiatives and business process optimization within a manufacturing environment.

• Demonstrated ability to lead technology transfers and manage complex manufacturing investigations.

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 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.