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Process Engineer UpstreamIdibu • Lucerne, Lucerne, Switzerland
Process Engineer Upstream

Process Engineer Upstream

Idibu • Lucerne, Lucerne, Switzerland
Vor 30+ Tagen
Stellenbeschreibung
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
  • Drivers license (B) and access to a personal car to enable on-call duties
Preferred Experience and Skills:

  • A bachelors or masters 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)



Employment Type : Full Time
Experience: years
Vacancy: 1
Yearly Salary Salary: CHF 88000 - 104000
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Process Engineer Upstream • Lucerne, Lucerne, Switzerland

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