Validation EngineerBeerse, Belgium
Since January 2018
1) designing, implementing and leading a custom agile based development approach for development of new Lab Automation Software within j&j's pdms afs. the newly developed Software will replace obsolete lea Software and will provide a user friendly top layer communicating with hamilton's and chemspeed's instrument control.
analyzing and mapping Lab Business Processes and screens and providing a Lab catalogue to clients and users, containing procedures, technical documents and manuals.
2) perform Validation activities according to j&j's sdlc (waterfall track) to support the implementation and Qualification of the syntq control client on a drug Manufacturing line. assess Validation needs and provide and follow up on necessary Documentation and milestones.
1) Designing, implementing and leading a custom Agile based development approach for development of new lab automation software within J&J's PDMS AFS. The newly developed software will replace obsolete LEA software and will provide a user friendly top layer communicating with Hamilton's and ChemSpeed's instrument control.
Analyzing and mapping lab business processes and screens and providing a lab catalogue to clients and users, containing procedures, technical documents and manuals.
2) Perform validation activities according to J&J's SDLC (Waterfall track) to support the implementation and qualification of the SYNTQ control client on a drug manufacturing line. Assess validation needs and provide and follow up on necessary documentation and milestones.
Regulatory Compliance ConsultantDiegem, Machelen, Belgium
Since September 2012
Validation engineer Beerse, BelgiumSeptember 2016 --- May 2017
1) designing and implementing a custom agile based development approach for development of new Lab Automation Software within j&j's pdms afs. the newly developed Software will replace obsolete lea Software and will provide a user friendly top layer communicating with hamilton's and chemspeed's instrument control.
Validation Engineer Beerse, BelgiumJuly 2016 --- August 2016
follow-up of Project Management and Validation activities during the holidays, replacing the Project Engineer responsible for a certain patient registration Software used in compassionate Treatment. acting on emergency changes, managing Validation activities, liaising between business stakeholders, Clinical it department and the Software vendor to ensure acceptance and validated state of the system. creating Validation Documentation and test scripts using hp alm. lead review and approval cycles.
Quality Engineer @ J&J Clinical Pharmacology UnitSeptember 2012 --- April 2015
responsible for Quality Management maintenance, development and continuous improvement, optimizing the cpu processes and Quality Systems. assuring the internal processes supported by systems, people and procedures comply with regulations. maintain inspection readiness, facilitate audits and inspections at cpu. set up, execute and reinforce programs for capa and deviation handling, Risk Management, internal audits and management review.
Product Researcher R&D Strombeek, Grimbergen, BelgiumMay 2010 --- August 2012
support new product initiatives and commercial initiatives on in-market products (dish washing liquids dept.), acting as the connection between product developers, Marketing and supporting functions. develop and validate test methods and sops to determine, compare and demonstrate product performance. Coach Lab personnel on accurate execution of these methods in line with sops.
AdaptabilityAnalytical thinkingAttention to detailFlexibilityKindnessProblem solvingReaction to stressSociabilityCollaboration
Quality ManagementCAPA Phase I R&DClinical pharmacologyClinical trial audits and inspectionsClinical trialsFDAGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)ICH-GCPInformed Consent ProcessIt skillsMicrosoft OfficeSOPTrainingValidationWriting Study Procedures and SOPs
Skills and Expertise
Create SOPs Guide students Report dataAdjust processes and methodsCoachCollaborate with medical teamDevelop ICH/GCP compliant processesEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesGuide staffImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Oral presentationPrepare internal auditsProvide trainingRespond to audit findingsSolve problemsTrain on site staffAgile methodologySDLCproject managementRegulatory documentation
Master in Industrial Sciences - Biochemistry from Groep T - Internationale Hogeschool Leuven in 2010