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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!
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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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