Job Description
We are looking for a Process Engineer - II - P2 Specialist, Manufacturing Operations 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: ASAP
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.
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).
* Mentoring and training junior team members and actively participating in knowledge transfer.
* Participating in sampling activities or being on-call, including potential weekend duties.
Requirements:
* Educational background in a relevant discipline.
* 2-5 years of experience in the pharmaceutical or biotech industry.
* Minimum of 2 years of practical experience in the GMP manufacturing of biologics (upstream or downstream).
* Expert knowledge in specific unit operations for 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 (B1 level).
Preferred Skills and Experience:
* Bachelor’s or Master’s degree in a relevant discipline.
* 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 activities.
* Ability to work efficiently as part of a team and independently on projects.
If you are interested, please submit your updated CV for consideration.
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