Process Engineer (Associate Specialist Downstream)

Client Overview

We represent a leading global biotechnology company, strategically located in the greater Lucerne area. This innovative manufacturing facility is dedicated to the development and production of biologic drug substances, focusing on clinical programs and technology innovation. The organization prides itself on delivering high-quality medicines through cutting-edge manufacturing technologies and a strong adherence to operational excellence and compliance.

Role Summary

We seek a motivated individual to support downstream manufacturing activities involved in the implementation and GMP manufacturing of early-phase clinical therapies. The role requires collaboration with cross-functional teams to execute manufacturing campaigns, troubleshoot technical issues, support process improvements, and uphold 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.

Candidate Profile

The ideal candidate will possess the following qualifications:

• Educational background in Biotechnology, Life Sciences, Chemical Engineering, Bioprocess Engineering, or a related discipline.
• 1-2 years of experience within the pharmaceutical or biotechnology industry.
• Experience working in a GMP-regulated manufacturing environment.
• Strong problem-solving skills with the ability to identify and resolve manufacturing process issues.
• Capacity 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.