Process Engineer

Process Engineer (Contract) Early-Phase Clinical Manufacturing

Location: Lucern, Switzerland

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.

Apply:
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.