Maastricht, Limburg, Netherlands
Technical supporting role within Validation Engineering team. Expert in: - Qualification of analytical lab equipment and process equipment qualification activities (IQ/OQ/PQ/CSV) - User Requirements Specifications. - IQ/OQ/PQ protocols/reports based on URS and if applicable on ISO standards. - Cleanroom qualification protocols, execution and (vendor) report reviews based on applicable ISO-14644 and Eudralex Volume 4 Annex 1 - Thermal mapping for temperature controlled units and rooms (LN2 storage, freezers, fridges, cold stores, ambient storage, incubators) - Facility/utilities (autoclave, VHP, clean steam, gas lines, water loop) - Airflow Visualisation Studies (smoke studies): static and dynamic AV Studies - BioSafety Cabinet qualification as per ISO-12469
As Team lead Validation Engineering responsible for: - Coördination/oversight of analytical lab equipment and process equipment qualification activities (IQ/OQ/PQ/CSV) - Writing/reviewing User Requirements Specifications. - Writing/reviewing IQ/OQ/PQ protocols/reports based on URS and if applicable on ISO standards and Eudralex guidelines. - Cleanroom validation protocols, execution and (vendor) report reviews based on applicable ISO standards and Eudralex guidelines. - Coördinator thermal mapping qualification activities (incl. protocol/report review) for equipment and rooms (LN2 storage, freezers, fridges, cold stores, ambient storage, incubators) - Facility/utilities validation activities (autoclave, VHP, clean steam, gas lines, water loop) - Airflow Visualisation Studies (smoke studies) including protocol preparation and reporting of static and dynamic AV Studies. Specialist in: - Thermal mapping (procedure writer/owner) - Airflow Visualisation Studies (procedure writer/owner) - Cleanroom and BioSafety Cabinet Validation (policy writer/owner) based on ISO standard and Eudralex.
Specialist in: - Thermal mapping (procedure writer/owner) - Airflow Visualisation Studies (procedure writer/owner) - Cleanroom and BioSafety Cabinet Validation (policy writer/owner) based on ISO standard and Eudralex.
- Trouble shooter/problem solver and analist of high-tech power -and digital electronics which fails during the production process. - Investigating quality issues caused during production and initiating preventive and corrective actions. - Technical support in case of functional test problems and related problems. - Link between Quality Assurance and Production. First 2 years responsible for a product group with 4 service engineers. Responsible for problem analysis of professional digital electronic products failed during production or during use at customer. First line production support in case of test problems and quality issues.
Test software development for testing digital electronic products. Responsible for quality analysis and improvements of digital electronic products during its life cycle. Production support in case of quality issues or test problems.
Hardware development of USB communication module used for laboratory measurement tools. Hardware design, PCB design, implementation and writing test software.
Technical support employee (ICT)