CK QLS

Process Engineer Upstream

Associate Specialist upstream Operations (12 months)

Description:

CK QLS is looking for an Associate Specialist to join a Global Biopharmaceutical company within their upstream Operations group, located in 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
• 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:

• Educational background in a relevant discipline

• 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)