We are looking for a Process Engineer - I (P1) Associate Specialist to join the Manufacturing Operations team for one of our clients. This full-time, on-site position is focused on supporting GMP manufacturing activities and ensuring seamless integration within the existing team.
Contract: temporary contract via Randstad
Start Date: 03/02/2025
End Date: 31/12/2026 (with the possibility of extension)
Location: Schachen, Luzern CH-6105, Switzerland, on site
Additional Information:
Candidates must either live in the surrounding area or be willing to relocate near Schachen, Luzern.
Job Description:
Responsibilities include but are not limited to:
- Setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
- Managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
- Contributing to continuous improvement initiatives and supporting the implementation of new technologies, including non-GMP engineering runs or testing activities.
- Creating and updating SOPs and electronic master batch records, as well as reviewing technical documentation for process transfer and GMP manufacturing.
- Material management using ERP systems (e.g., SAP).
- Participating in sampling activities or being on-call, including potential weekend duties.
Requirements:
- Educational background in a relevant discipline.
- 1-2 years of experience in the pharmaceutical or biotech industry.
- Familiarity with upstream or downstream processes and general knowledge of unit operations in biologics manufacturing.
- Understanding of GMP principles and the ability to work under pressure in a complex environment.
- Fluent English communication skills (C1 level).
- Intermediate German skills (B2 level). Candidates with German A1/B1 proficiency may be considered if other skills are highly aligned.
Preferred Skills and Experience:
- Bachelor’s or Master’s degree in a relevant discipline.
- 1-2 years of experience in a GMP environment.
- Familiarity with quality management and compliance systems (e.g., Trackwise, SAP QM, VeevaVault).
- Experience with automated systems (DeltaV) or electronic batch records (MES).
- Previous experience with process development or scale-up.
If you are interested, please submit your updated CV for consideration.
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