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.
- 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).
- 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.
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 114 363 in all correspondence.