Process Engineer

Process Engineer (Associate Specialist Downstream)

Client Description

For one of our clients, a leading global biotechnology company located in the greater Lucerne area, we are currently seeking a Process Engineer (Associate Specialist Downstream Operations) (m/f/d) to join a state-of-the-art biologics manufacturing facility in Lucerne area.

This innovative manufacturing site specializes in the development and production of biologic drug substances for clinical programs and technology innovation initiatives. The organization is committed to delivering high-quality medicines through advanced manufacturing technologies, operational excellence, and a strong culture of quality and compliance.

About the Role

We are looking for a motivated Process Engineer (Associate Specialist Downstream Operations) (m/f/d) to support downstream manufacturing activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

In this role, you will be responsible for supporting purification and manufacturing processes within a GMP-regulated biotech environment. You will work closely with cross-functional teams to execute manufacturing campaigns, troubleshoot technical issues, support process improvements, and ensure compliance with quality and safety standards.

Your Responsibilities

• Process Engineer (Associate Specialist Downstream)
• Set up, execute, and troubleshoot downstream manufacturing processes under GMP conditions.
• Ensure compliance with GMP principles and EHS standards within the area of responsibility.
• Support continuous improvement initiatives and implementation of new manufacturing technologies.
• Participate in non-GMP engineering runs and testing activities as required.
• Create and update Standard Operating Procedures (SOPs) and electronic master batch records.
• Perform technical review of manufacturing and process transfer documentation.
• Support material management activities using SAP.
• Participate in process sampling activities and provide operational support during manufacturing campaigns.
• Collaborate with manufacturing, quality, and engineering teams to ensure successful execution of production activities.