Freelance

• Jan 2022 - Present

Staff Supplier Quality Engineer via Pauwels Consulting

• Sep 2021 - Present

Responsible for developing, managing and maintaining Supplier Quality Management Metrics to enable proactive, metric-driven management of the Quality Supplier relationships and purchasing controls processes commensurate with the risk to product safety and efficacy. Responsible for developing, managing and maintaining Supplier Quality Management Metrics to enable proactive, metric-driven management of the Quality Supplier relationships and purchasing controls processes commensurate with the risk to product safety and efficacy.

Consultant

• Sep 2021 - Present

Pharmaceutical Process Engineer

• Feb 2019 - Sep 2021

• Writing and executing qualification protocols (IOQ /PQ), including identification and resolution of non-conformances/deviations and changes and write summary reports for IOQ / PQ testing • Performing risk assessments to provide equipment, systems and facilities qualification guidance • Shaping the architecture for qualification documentation • Providing improvement opportunities • Participating in the execution of engineering projects (e.g. deviations, improvements) • Ensuring that qualification activities are performed timely and within budget • Establishment, implementation, reporting and/or coordination of investigations and changes to improve existing installations and production processes Show less

Quality Engineer Coördinator

• Dec 2016 - Feb 2019

Perform and coordinate the handling of deviations, CAPAs, changes and observations for the facility.Testing and verification of compliance with quality regulations and reports. Ensure adequate follow-up when defects have been identified.Coordinating of all Quality attributes of the facilityProviding quality responsibility.Optimize the quality system.Set up and check SOPs, BDIs, reports and other quality records.OTJ trainings and classroom training.Process validation/ Cleaning validation/ QualificationResponsible for performing and writing process and equipment qualifications. (IOQ / PQ) Show less

Head Operator/ Qualification Engineer

• Mar 2016 - Dec 2016

Primarily involved in the production set up of the polio vaccine, in building A 10. Accompanies (aseptic) upstream and downstream processes under GMP - and BSL-3 conditions. Also responsible for validation status of the equipment, including its documentation. Such as system files, logs,validations plan performance and periodic evaluations and the quality of the equipment.

Senior Operator

• Aug 2015 - Mar 2016

Bilthoven Biologicals is one of the four inactivated polio vaccine producers in the world. As Senior Operator responaible process and improvement of viral vaccine polio.

Manufacturing Operator Purificatie

• Jul 2013 - Jul 2015

Manufacturing Operator at DSP. GMP manufacturing of bulk drug substances and drug products. Manufacturing Operator at DSP. GMP manufacturing of bulk drug substances and drug products.

Biotech Operator

• Mar 2011 - Mar 2013

As Biotech Operator at Janssen BV department Down Stream Processing. Purification of the product obtained by means of various column chromatography steps. As Biotech Operator at Janssen BV department Down Stream Processing. Purification of the product obtained by means of various column chromatography steps.

Research Assistant

• Feb 2012 - Jul 2012

Research internship: Verification study of 5-L bioreactors by a comparison cell culture performance between 10-L and 500L-scale C168J cell cultures. Grade 8.5 Research internship: Verification study of 5-L bioreactors by a comparison cell culture performance between 10-L and 500L-scale C168J cell cultures. Grade 8.5

BTO technichian

• Mar 2010 - Mar 2011

Resposible for the production of food supplements (medium) for the different cell cultures in the fermentation process. Resposible for the production of food supplements (medium) for the different cell cultures in the fermentation process.

QC analyst

• Mar 2009 - Mar 2010

The measurement of salt, acid, pH and viscosity of various Heinz products. If the measured values were between the critical values, then approval for production is given. The measurement of salt, acid, pH and viscosity of various Heinz products. If the measured values were between the critical values, then approval for production is given.

Catering

• 2007 - 2008

Taking care of the catering for different celebrations and events. Taking care of the catering for different celebrations and events.