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CSV Engineer

Job ID: #

ECSV101

Description

As a CSV Specialist, you will be responsible for testing and qualifying process installations and equipment. Additionally, you will organize and oversee testing and qualification/validation activities, acting as the point of contact for relevant departments (such as Production, QA/QC).
Do you have experience with qualification projects? Have you worked within a GMP, GLP, GDP or ISO 13485 environment? If so, please read on!

Company:

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Hours per week:

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Requirements
  • Experience and knowledge of automated systems and automation (e.g., data security, data exchange, infrastructure, PLC (Siemens), SCADA, LIMS, MES systems (Siemens, Syncade, Werum Pas-X), ERP (SAP, Oracle), Industry 4.0, Rockwell, FactoryTalk, etc.).

  • Bachelor’s – or Master’s degree and work experience in a relevant environment.

  • Experience and knowledge of Life Sciences & Healthcare production processes and regulations such as GMP, GDP, and ISO 13485.

  • Familiarity with working according to GAMP 5 and current knowledge of 21 CFR Part 11.

  • Proficiency in Dutch, English. German/French is a plus.

  • Knowledge and experience with risk analysis methods, improvement methods, and techniques (V-model, Lean Six Sigma).

Key Responsibilities
  • Develop qualification plans, specifications, User Acceptance Test protocols, qualification reports, SOPs, and Work Instructions.

  • Validate and report on automation in processes and equipment, for which you will also be responsible.

  • Initiate and review validation documents.

  • Identify, initiate, and implement improvements for GMP documentation.

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