Process Engineer - I.

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.