Process Engineer – Upstream Operations (12 Months)
CK QLS · Lucerne
Description du poste
About the role
This is an Associate Specialist position within the Upstream Operations group, based in the greater Lucerne area. It is a 12-month assignment requiring full-time physical presence at the site to support manufacturing and integrate into an existing team. You will support the implementation and GMP manufacturing of early-phase clinical therapies.
Key responsibilities
- Set up, run and troubleshoot upstream processes under Good Manufacturing Practices (GMP)
- Ensure knowledge of and compliance with GMP principles and EHS standards in your area of responsibility
- Take part in continuous improvement and support new technologies, including non-GMP engineering runs or testing
- Create and update SOPs and electronic master batch records, and review documentation for process transfer and GMP manufacturing
- Manage materials using ERP systems (SAP)
- Participate in sampling activities (including occasional weekend work) or on-call duties as needed; typical manufacturing does not involve shift work
Required profile
- Bachelor's or master's degree in a relevant discipline preferred
- At least 1-2 years of experience in the pharmaceutical or biotech industry
- Fluent English and German
- Residence within about 30 minutes of Schachen (LU) or willingness to relocate
- Driver's licence (B) and access to a personal car for on-call duties
Required skills
- Preferred: prior experience manufacturing biologics under GMP, including shake flask work, wave systems and single-use bioreactors
- Preferred: familiarity with automated manufacturing systems (DeltaV) and electronic batch records (PAS-X)
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CK QLS
Lucerne