Process Engineer USP Operations

CK QLS; Luzern; On-site; CHF 70,000 - 90,000; Full time

Job summary

CK QLS is seeking an Associate Specialist Upstream Operations in the greater Lucerne area for a 12-month, full-time position. You will support GMP manufacturing of early-phase therapies and work closely with the manufacturing team to integrate into an established operation.

Responsibilities include setting up and troubleshooting upstream processes, ensuring GMP and EHS compliance, contributing to continuous improvement, and maintaining SOPs and batch records.

Qualifications

• Bachelor’s or Master’s degree in a relevant discipline preferred.
• 1–2 years of work experience in the pharmaceutical or biotech industry.
• Ability to solve problems and continuously learn and develop.
• Ability to perform under pressure in a GMP environment and collaborate with stakeholders to achieve targets.
• Business fluent in English and German.
• Residence within ~30 minutes commuting distance from Schachen (LU) or willingness to relocate.
• Driver’s license (B) and access to a personal car for on-call duties.

Responsibilities

• Set up, practical execution and troubleshooting of upstream processes under GMP.
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility.
• Involvement in continuous improvement 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 process transfer and GMP manufacturing documentation.
• 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.

Skills

GMP manufacturing

Problem solving

Cross-functional collaboration

English & German

Education

Bachelor's or Master’s degree

Tools

DeltaV

PAS-X

Job description

Associate Specialist Upstream Operations (12 months)

This is an Associate Specialist position within the Upstream Operations group at our company in the greater Lucerne area. This position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an 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 upstream 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 bachelor’s or master’s degree in a relevant discipline is preferred
• 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
• 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:

• Prior experience in the manufacturing of biologics under GMP, ideally including experience operating a shake flask work, wave systems, and single-use bioreactors
• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)