Process Engineer, Lucerne

Vor 2 Tagen

Luzern, Schweiz TN Switzerland Vollzeit

Process Engineer (Contract) – Early-Phase Clinical Manufacturing

Company: CK QLS (on behalf of our client)

CK QLS are seeking a Process Engineer to join a dynamic and growing manufacturing team within the pharmaceutical industry. This contract-based role offers the opportunity to support the implementation and GMP manufacturing of early-phase clinical therapies. The successful candidate will be responsible for ensuring the smooth execution of key manufacturing processes and contributing to continuous improvement efforts in a fast-paced and highly regulated environment.

Key Responsibilities:

  • Set up, execute, and troubleshoot upstream, downstream, and support operations in continuous manufacturing and fed-batch processes under GMP guidelines.
  • Ensure compliance with GMP principles, Environmental Health and Safety (EHS) standards, and company policies.
  • Document and manage process execution, deviations, changes, and Corrective and Preventive Actions (CAPAs).
  • Contribute to continuous improvement initiatives and the integration of new technologies in the manufacturing process.
  • Create, update, and maintain Standard Operating Procedures (SOPs) and master batch records.
  • Manage materials and inventory using ERP systems such as SAP.
  • Participate in sampling activities and on-call duties, which may include weekend work.

Requirements:

  • Degree in a relevant scientific or engineering discipline.
  • 0-2 years of experience in the pharmaceutical or biotech industry.
  • Strong knowledge of upstream or downstream processes and GMP requirements.
  • Solid problem-solving abilities and adaptability in a GMP-compliant environment.
  • Proficiency in English (C1 level) and German (B2 level).

Preferred Qualifications:

  • A Bachelor's or Master's degree in a relevant field.
  • Experience working in a GMP-regulated environment.
  • Familiarity with quality management systems and automated manufacturing systems.
  • Ability to work collaboratively within a team as well as independently.
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