Senior Bioprocess Engineer, Downstream Processing (DSP)

Serve as the senior technical expert for downstream processing manufacturing campaigns, ensuring safe, compliant, and reliable execution of purification operations in a GMP environment. Provide hands-on shop floor support during campaign preparation, execution, and close-out activities, acting as the escalation point for complex operational challenges. Lead technical investigations, root cause analyses, CAPAs, change controls, and risk assessments to resolve process deviations and support manufacturing excellence. Analyze process performance data to identify trends and implement solutions that improve plant throughput, process robustness, equipment reliability, yields, and cycle times. Provide subject matter expertise in chromatography, resin management, column packing, tangential flow filtration (TFF), UF/DF operations, bulk drug substance handling, and final processing activities. Partner closely with Manufacturing, MSAT, Quality Assurance, Quality Control, Validation, Engineering, and Supply Chain teams to support technology transfers, process validation, and operational readiness activities. Drive continuous improvement initiatives and mentor junior engineers and manufacturing personnel to strengthen technical capability, operational performance, and right-first-time execution.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees.

• 10+ years of experience supporting GMP downstream processing operations within commercial or late-stage biopharmaceutical manufacturing environments, with a strong presence on the manufacturing floor.

• Proven expertise in chromatography systems, purification processes, TFF/UFDF operations, and DSP process optimization.

• Demonstrated ability to troubleshoot complex process, equipment, and operational issues and implement sustainable solutions in a GMP environment.

• Strong experience with deviation investigations, root cause analysis, CAPA management, change controls, risk assessments, and GMP documentation requirements.

• Ability to use process and operational data to drive decision-making, performance improvements, and manufacturing excellence.

• Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Life Sciences, or a related discipline, or equivalent industry experience.

• Excellent communication, collaboration, and stakeholder management skills, with experience leading cross-functional initiatives and mentoring technical teams.