{"id":7069394,"date":"2026-07-17T14:48:26","date_gmt":"2026-07-17T14:48:26","guid":{"rendered":"https:\/\/jeffersonwells.be\/vacancies\/27956-project-engineer-cleanroom-validation\/"},"modified":"2026-07-17T14:48:26","modified_gmt":"2026-07-17T14:48:26","slug":"27956-project-engineer-cleanroom-validation","status":"publish","type":"matador-job-listings","link":"https:\/\/jeffersonwells.be\/nl\/vacancies\/27956-project-engineer-cleanroom-validation\/","title":{"rendered":"Project Engineer Cleanroom Validation"},"content":{"rendered":" <ul class=\"matador-job-meta matador-job-meta-job-7069394 matador-job-meta-default\"> <li class=\"matador-job-meta-field matador-job-field-job_general_location matador-job-field-value-puurs\"> <span class=\"matador-job-meta-label\">Locatie:<\/span> <span class=\"matador-job-meta-value\">Puurs<\/span> <\/li> <li class=\"matador-job-meta-field matador-job-field-bullhorn_job_id matador-job-field-value-27956\"> <span class=\"matador-job-meta-label\">Vacature<\/span> <span class=\"matador-job-meta-value\">#27956<\/span> <\/li> <\/ul> <h1><strong>Project Engineer Cleanroom Validation<\/strong><\/h1> <p><strong>Contracting &#8211; Antwerp<\/strong><\/p> <p><strong>Takenpakket<\/strong><\/p> <ul> <li>Co\u00f6rdineren en ondersteunen van kwalificatie- en validatieactiviteiten voor cleanrooms, HVAC-systemen en gebouwgebonden voorzieningen. <li>Opstellen, reviewen en uitvoeren van validatiedocumentatie zoals: <ul> <li>Validation Plans <li>Risk Assessments <li>IQ\/OQ\/PQ protocollen <li>Traceability matrices <li>Validation Reports <\/ul> <li>Ondersteunen van commissioning- en verificatieactiviteiten tijdens projectuitvoering. <li>Defini\u00ebren en opvolgen van GMP-vereisten tijdens ontwerp en constructie van cleanroomprojecten. <\/ul> <p><strong>Quality Systems<\/strong><\/p> <ul> <li>Initi\u00ebren en beheren van Change Control Requests. <li>Opstellen, onderzoeken en opvolgen van afwijkingen (Deviations). <li>Implementeren en bewaken van CAPA&apos;s. <li>Uitvoeren van periodieke reviews van lifecycle-documentatie. <li>Beoordelen van impactanalyses in het kader van wijzigingen aan GMP-kritische systemen. <\/ul> <p><strong>Compliance &amp; Audit Readiness<\/strong><\/p> <ul> <li>Zorgen voor een continue audit- en inspectiegereedheid van het Building team. <li>Ondersteunen van interne audits en inspecties door klanten en gezondheidsautoriteiten. <li>Opvolgen van nieuwe GMP-richtlijnen en farmaceutische regelgeving. <li>Vertalen van gewijzigde wet- en regelgeving naar concrete verbeteracties binnen de afdeling. <\/ul> <p><strong>Continuous Improvement<\/strong><\/p> <ul> <li>Identificeren en implementeren van verbeteringen binnen validatieprocessen. <li>Standaardiseren van validatiemethodieken en documentatie. <li>Delen van kennis en ondersteunen van projectingenieurs op vlak van GMP en validatie. <\/ul> <p><strong>Functieprofiel<\/strong><\/p> <ul> <li>Master of Bachelor in een technische of wetenschappelijke richting (Ingenieur, Bio-ingenieur, Industri\u00eble Wetenschappen, Farmaceutische Wetenschappen of gelijkwaardig door ervaring). <li>Goede kennis van GMP-regelgeving en validatieprincipes. <li>Ervaring met qualification &amp; validation documentatie (IQ\/OQ\/PQ). <li>Perfecte beheersing van het Nederlands en Engels. <li>Sterke communicatieve vaardigheden. <li>Kritisch en analytisch denkvermogen. <li>Sterk organisatorisch vermogen en nauwkeurige werkstijl. <li>In staat om zelfstandig projecten en acties op te volgen. <li>Administratief sterk met aandacht voor kwaliteit en compliance. <\/ul> <p><strong>Nice to Have<\/strong><\/p> <ul> <li>Ervaring met cleanroomkwalificatie en HVAC-validatie. <li>Ervaring binnen een farmaceutische of biotechnologische GMP-omgeving. <li>Kennis van Annex 1, ISPE Baseline Guides en ASTM\/ISO richtlijnen voor cleanrooms. <li>Ervaring met Change Control, Deviations en CAPA-processen. <li>Ervaring met commissioning en qualification van utilities, HVAC- of gebouwsystemen. <li>Enthousiaste teamspeler die graag samenwerkt in multidisciplinaire projectteams. <\/ul> <nav class=\"matador-job-navigation\"> <ul> <li> <a href=\"https:\/\/jeffersonwells.be\/nl\/vacancies\/27956-project-engineer-cleanroom-validation\/\" rel=\"button\" class=\"matador-button\" title=\"Solliciteren Direct\">Solliciteren Direct<\/a> <\/li> <\/ul> <\/nav> ","protected":false},"excerpt":{"rendered":"<p>Locatie: Puurs Vacature #27956 Project Engineer Cleanroom Validation Contracting &#8211; Antwerp Takenpakket Co\u00f6rdineren en ondersteunen van kwalificatie- en validatieactiviteiten voor cleanrooms, HVAC-systemen en gebouwgebonden voorzieningen. Opstellen, reviewen en uitvoeren van validatiedocumentatie zoals: Validation Plans Risk Assessments IQ\/OQ\/PQ protocollen Traceability matrices Validation Reports Ondersteunen van commissioning- en verificatieactiviteiten tijdens projectuitvoering. Defini\u00ebren en opvolgen van GMP-vereisten tijdens &hellip; <a href=\"https:\/\/jeffersonwells.be\/nl\/vacancies\/27956-project-engineer-cleanroom-validation\/\" class=\"more-link\">Lees verder <span class=\"screen-reader-text\">&#8220;Project Engineer Cleanroom Validation&#8221;<\/span><\/a><\/p>\n","protected":false},"template":"","meta":{"_matador_source_id":"27956"},"matador-categories":[1420592],"matador-locations":[1419977],"matador-types":[1419976],"matador-provinces":[1420470],"class_list":["post-7069394","matador-job-listings","type-matador-job-listings","status-publish","hentry","matador-categories-life-sciences","matador-locations-puurs","matador-types-contracting","matador-provinces-antwerp"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Project Engineer Cleanroom Validation - Jefferson Wells<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jeffersonwells.be\/vacancies\/27956-project-engineer-cleanroom-validation\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Project Engineer Cleanroom Validation - Jefferson Wells\" \/>\n<meta property=\"og:description\" content=\"Locatie: Puurs Vacature #27956 Project Engineer Cleanroom Validation Contracting &#8211; Antwerp Takenpakket Co\u00f6rdineren en ondersteunen van kwalificatie- en validatieactiviteiten voor cleanrooms, HVAC-systemen en gebouwgebonden voorzieningen. Opstellen, reviewen en uitvoeren van validatiedocumentatie zoals: Validation Plans Risk Assessments IQ\/OQ\/PQ protocollen Traceability matrices Validation Reports Ondersteunen van commissioning- en verificatieactiviteiten tijdens projectuitvoering. 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