About the Role
CQV Engineer – Groningen, Netherlands
Start date: June 2025
Duration: 6 months
Onsite: Full time (Monday – Friday)
Hours per week: 45
We are looking for a Validation Engineer on a long term construction project based in Groningen, Netherlands.
We will pay €3500 of the expansible receipts per month.
The CQV Engineer should have adequate knowledge of one or more of the following: Gap analysis, process validation, commissioning, validation documentation, full validation lifecycle.
Job Responsibilities
• Working on a Pharmaceutical facility in the CQV department where you will be assisting IQ,OQ,PQ of medical equipment. Qualification requirements for new/improved machines/processes, including system requirements / design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Senior Quality Engineer. This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
• Working on a variety of medical equipment including.
• Supports the manufacturing plant through implementation of process improvements.
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives improvements.
• Manage small projects (both new and improvement) to include cost, implementation, and validation.
• Provides statistical assistance to Quality and Production.
• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments, and general information reports for use by management.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assist in evaluation of customer complaints, risk management and technical summaries.
• Assist in evaluation of supplier product/process changes.
• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.