Process Engineer - DSP

CK QLS; Luzern; Vor Ort; CHF 70.000 - 90.000; Vollzeit

Zusammenfassung

CK QLS is seeking an Associate Specialist in Downstream Operations for a 12-month, full-time on-site role in the greater Lucerne area. The position focuses on supporting GMP manufacturing of early-stage therapies, with responsibilities spanning setup, execution, and documentation of downstream processes.

The candidate should have 1–2 years of pharma/biotech experience, strong problem-solving skills, and fluent German (C1) and English (B2+). Relocation to Schachen vicinity is welcomed.

Qualifikationen

• Minimum 1–2 years in pharmaceutical or biotech industry.
• Must solve problems and adapt to new perspectives.
• Strong communication in German (C1) and English (B2+).
• Residence within ~30 minutes of Schachen (LU) or willing to relocate.

Aufgaben

• Set up, execute, and troubleshoot downstream processes under GMP.
• Ensure GMP and EHS compliance in the area of responsibility.
• Support implementation of new technologies and non-GMP engineering runs or testing.
• Create and update SOPs and electronic master batch records; perform technical reviews.

Kenntnisse

GMP manufacturing

Problem solving

Team collaboration

English & German fluency

Ausbildung

Bachelor’s or Master’s in a relevant discipline

Tools

DeltaV

PAS-X

Electronic batch records

Jobbeschreibung

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
• 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)