Process Engineer

Vor 3 Tagen

Schachen LU, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription

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: 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.

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 (B2 level). Candidates with German A1/B1 proficiency may be considered if other skills strongly align with the role.

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.

Luciana Sardo

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