Process Engineer

Vor 2 Tagen

Luzern, Schweiz Randstad (Schweiz) AG Vollzeit

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:

  1. Setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
  2. Managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
  3. Contributing to continuous improvement initiatives and supporting the implementation of new technologies, including non-GMP engineering runs or testing activities.
  4. Creating and updating SOPs and electronic master batch records, as well as reviewing technical documentation for process transfer and GMP manufacturing.
  5. Material management using ERP systems (e.g., SAP).
  6. Mentoring and training junior team members and actively participating in knowledge transfer.
  7. Participating in sampling activities or being on-call, including potential weekend duties.

Requirements:

  1. Educational background in a relevant discipline.
  2. 2-5 years of experience in the pharmaceutical or biotech industry.
  3. Minimum of 2 years of practical experience in the GMP manufacturing of biologics (upstream or downstream).
  4. Expert knowledge in specific unit operations for biologics manufacturing.
  5. Understanding of GMP principles and the ability to work under pressure in a complex environment.
  6. Fluent English communication skills (C1 level).
  7. 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:

  1. Bachelor’s or Master’s degree in a relevant discipline.
  2. Familiarity with quality management and compliance systems (e.g., Trackwise, SAP QM, VeevaVault).
  3. Experience with automated systems (DeltaV) or electronic batch records (MES).
  4. Previous experience with process development or scale-up activities.
  5. 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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