Bioprocess Engineer USP

Plan, execute, and oversee USP manufacturing campaigns, ensuring safety, quality standards, and on‑time‑in‑full delivery. Evaluate process performance, interpret test results, troubleshoot USP equipment, and recommend solutions to operational issues. Prepare and execute SHE, EM, operational, and cleaning risk assessments for assigned products. Author, review, and maintain GMP‑relevant documents, SOPs, tech transfer documentation, recipes, and EBRs. Prepare, review, and support quality records including deviations, change controls, CAPAs, and investigations. Perform or support qualification activities for equipment, manufacturing suites, and automation systems (MES/DeltaV). Lead USP operational readiness activities, including process validation, training, in‑process control, and other startup‑phase deliverables.

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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• A BSc or MSc in a relevant scientific or engineering discipline with proven experience in USP manufacturing, or a candidate without an academic degree but with 7+ years of hands‑on experience in USP operations or a similar role.

• Solid expertise in GMP environments, USP workflows, troubleshooting, and bioprocess equipment.

• Experience with MES/DeltaV recipe creation, execution, or review is a strong advantage.

• Structured and proactive way of working with the ability to collaborate effectively with cross‑functional teams.

• Strong communication skills and readiness to support customer audits.

• Ability to lead tasks independently and contribute to continuous improvement and operational excellence.

• Willingness to participate in on‑call duty/Pikett.