Process Engineer (Associate Specialist Downstream)

more-jobs; Luzern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

more-jobs is seeking a Process Engineer (Associate Specialist Downstream Operations) in the Lucerne area to support GMP manufacturing for early-phase biologics therapies. You will work onsite, coordinating purification steps, SOPs, and cross‑functional teams within a state‑of‑the‑art facility.

The role requires 1–2 years in pharma/biotech GMP, German (C1) and English (B2+) communication, and a willingness to be onsite with occasional on-call duties. 12-month contract with potential extension.

Qualifikationen

• Educational background in Biotechnology, Life Sciences, Chemical Engineering or related discipline.
• 1-2 years of experience in pharma/biotech GMP environment is preferred.
• Strong problem‑solving and cross‑functional collaboration abilities.

Aufgaben

• Set up, execute, and troubleshoot downstream manufacturing processes under GMP conditions.
• Ensure GMP and EHS compliance within area of responsibility.
• Support process improvements and implementation of new technologies.
• Participate in non-GMP engineering runs and testing activities as required.
• Create and update SOPs and electronic master batch records.
• Review manufacturing and process transfer documentation.

Kenntnisse

Problem solving

Communication

Team collaboration

German language

English language

Ausbildung

Bachelor's or Master's in Biotechnology/Life Sciences/Chemical Engineering

Tools

DeltaV

PAS-X

SAP

Chromatography

Virus filtration

UF/DF

Formulation

Fill & Freeze

Jobbeschreibung

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

• 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.

Your 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.

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