Process Engineer - DSP

CK QLS; Luzern; On-site; CHF 70,000 - 100,000; Full time

Job summary

CK QLS seeks an Associate Specialist in Downstream Operations for a 12-month, full-time on-site role in the Lucerne area. You will support GMP manufacturing of early-phase therapies, contribute to process setup and optimization, and ensure adherence to GMP/EHS standards while coordinating with internal and external stakeholders.

Applicants should have 1–2 years in pharma/biotech, a relevant degree, and proficiency in English and German, with a driver’s license for on-call duties.

Qualifications

• 1-2 years of experience in pharmaceutical or biotech industries.
• Ability to solve problems and continuously learn and improve.
• Ability to perform under pressure in GMP environments and coordinate with stakeholders.
• Proficiency in speaking and writing English and German.
• Residence within ~30 minutes of Schachen (LU) or willingness to relocate.
• Driver’s license (B) and access to a car for on-call duties.

Responsibilities

• Set up, execute, and troubleshoot downstream processes under GMP.
• Maintain GMP and EHS standards; ensure compliance.
• Support continuous improvement and new tech implementations, including non-GMP runs.
• Create/update SOPs and electronic master batch records; perform technical reviews.
• Manage materials using SAP ERP; participate in sampling and on-call duties.
• Note: typical manufacturing activities do not involve shift work.

Skills

GMP experience

German (C1)

English (B2+)

Problem solving

Communication skills

Team collaboration

Relocation willingness

Driver's license

Education

Bachelor's degree

Master's degree

Tools

SAP

DeltaV

PAS-X

Job description

Associate Specialist Downstream Operations (12 months)

Duration: 1 year

This is an Associate Specialist position within the Downstream Operations group at our company in the greater Lucerne area. This role requires full-time on-site presence to support manufacturing and integrate seamlessly with the existing team.

As a member of the manufacturing team at our company, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

Responsibilities would primarily entail, but are not limited to, the following:

• Set up, practical execution and troubleshooting of downstream processes under Good Manufacturing Practices (GMP)
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
• Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities
• Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing
• Material management using ERP systems (SAP)
• Participation in sampling activities (including occasional weekend work) or on-call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work.

To be successful in this role, you will have the following:

• A minimum of 1-2 years of work experience in the pharmaceutical or biotech industry.
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Ability to perform under pressure in a complex GMP environment and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.
• Business Fluent in English and German:
• Effective oral / written communication skills in German (C1) & Oral / written communication skills in English (B2+)
• Residence within approximately 30 minutes commuting distance from Schachen (LU) or willingness to relocate
• Driver’s license (B) and access to a personal car to enable on-call duties

Preferred Experience and Skills:

• A bachelor’s or master’s degree in a relevant discipline
• Prior experience in the manufacturing of biologics under GMP, ideally including experience operating capturing and polishing chromatography, virus filtration, UFDF, formulation, fill & freeze
• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)