Mechelen, Flemish Region, Belgium
30 years of engineering experience, of which * 3 years as a process engineer in basic and detail design for (petro)chemical plants * 21 years as a (senior) validation engineer in pharmaceutical companies (Janssen Pharmaceutica, Schering-Plough Labo / MSD, Ely Lilly, Pfizer, GSK) * 4 years as an Safety engineer, assisting on different activiteis (explosion zoning plan update, facility siting analysis, machinery directive...)
Opstellen van een handleiding voor de verschillende units van de installatie.
Uitwerking van het procesgedeelte van kleinere wijzigingen, in samenwerking met piping, E&I, en andere disciplines. Eerste benaderende berekeningen op fysische haalbaarheid. Deelname aan HAZOP-sessies en opvolging actiepunten.
* Planning and follow-up of validation projects * Writing Validation Plans, Qualification Protocols (IQ, OQ, PQ) and Qualification Reports for pharmaceutical equipment (mixing vessels, granulators, tablet presses, packaging lines) and utilities (compressed air, nitrogen, purifies water) * Executing Qualification Protocols (testing) * Consulting on Qualification matters
* Writing Validation Plans, Qualification Protocols (IQ, OQ, PQ) and Qualification Reports for pharmaceutical equipment (mixing vessels, granulators, tablet presses, packaging lines) and utilities (compressed air, nitrogen, purifies water) * Executing Qualification Protocols (testing)
* Performing basic and detailed engineering calculations on equipment (pumps, vessels, piping, ...) for (petro)chemical plants.
EHS support engineer for the New Raw Materials Storage Vessels project * Setup of the file 'Indienststellingsonderzoek' for EHS (J&J internal EHS requirements) * Setup of the file for the legal approval of the storage vessels (governmental requirements)
Senior Process/Validation Engineer - Green Tag / Blue Tag Commissioning & Qualification - Plant 3 Renovation • Assisting in adjustment of Green Tag and Blue Tag approach • Review of technical documents • Issue of Green Tag and Blue Tag Protocols (= extended commissioning, with document requirements on qualification level) • Follow up on Green Tag tests by contractors • Execution of Blue Tag tests (document reviews and field tests) • Issue of Blue Tag Reports + follow up on completion status • Trouble shooting • Responsible for P&IDs, Line List and Component List master copies • Assistance to C&Q Lead