Process Engineer (Associate Specialist Downstream)

Process Engineer (Associate Specialist Downstream Operations)

Join a leading global biotechnology company in the greater Lucerne area to support downstream manufacturing activities within a state-of-the-art biologics manufacturing facility. This innovative site specializes in the development and production of biologic drug substances for clinical programs and technology innovation initiatives, committed to delivering high-quality medicines through advanced manufacturing technologies, operational excellence, and a strong culture of quality and compliance.

Role Overview

Support the implementation and GMP manufacturing of early-phase clinical therapies by managing purification and manufacturing processes within a GMP-regulated biotech environment. Work closely with cross-functional teams to execute manufacturing campaigns, troubleshoot technical issues, support process improvements, and ensure compliance with quality and safety standards.

Key Responsibilities

• 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 the 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.

Required Profile

• Educational background in Biotechnology, Life Sciences, Chemical Engineering, Bioprocess Engineering, or a related discipline.
• Minimum 1-2 years of experience within the pharmaceutical or biotechnology industry.
• Experience working in a GMP-regulated manufacturing environment.
• Strong problem-solving skills and ability to identify and resolve manufacturing process issues.
• Ability to work effectively in a dynamic and complex manufacturing environment.
• Professional communication skills in German (C1) and English (B2+).
• Willingness to work onsite and participate in occasional on-call duties.

Preferred Qualifications

• Bachelor's or Master's degree in a relevant scientific discipline.
• Experience in biologics manufacturing operations.
• Hands-on experience with chromatography, virus filtration, UF/DF, formulation, or fill & freeze processes.
• Familiarity with manufacturing systems such as DeltaV, PAS-X, and SAP.

Additional Information

• Location: Lucerne Area
• Contract Duration: 12-month contract position
• Employment Type: Temporary Staffing
• Work Model: 100% Onsite
• Working Hours: 40 hours per week
• On-Call Requirement: Occasional on-call duties may be required based on manufacturing schedules.