QA-CSV & Digitalization Site Key User (F/M/X)

pPermanent Job /p pJoin our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization. /p pIn this combined role, you will support two complementary areas within a GxP manufacturing environment. You will provide independent QA-CSV oversight and practical validation support for execution systems, while also acting as the Site Key User for Checklyst Manager, a core digitalization system supporting the transition from paper to controlled digital checklists. This position is critical to ensuring robust quality assurance, data integrity, and digital transformation across the site. /p h3Your missions /h3 ul liProvide QA-CSV support for PLC and SCADA-based automation and visualization systems, particle and environmental monitoring systems, and automation network shared services (including Active Directory, access and policy management, backup and restore, patching, antivirus, and infrastructure monitoring). /li liReview and approve validation deliverables, including assessments, plans, requirements, risk assessments, specifications, test documentation, traceability, and summary reports. /li liAssess changes, incidents, deviations, defects, and CAPAs for impact on product quality, patient safety, data integrity, and validated state. /li liApply a pragmatic, risk-based approach focused on critical functions, data, interfaces, and controls. /li liAssess controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention, and data transfer. /li liSupport data-flow mapping, inspection readiness, periodic reviews, and elevate material quality risks as needed. /li liCoordinate and oversee the creation, configuration, testing, and documentation of new digital checklists in Checklyst Manager. /li liEnsure new or changed checklists are reviewed, tested, approved, and released before operational use. /li liOnboard new areas and teams, align on intended use, responsibilities, training, and readiness for adoption. /li liGovern user access, support timely provisioning, modification, and removal of access, and periodically review roles and responsibilities within the system. /li liProvide first-line functional guidance to users, authors, reviewers, and area representatives, and coordinate escalation of system issues. /li liRun and review system and process metrics, identify overdue or non-compliant records, and coordinate follow-up actions. /li liEnsure records are controlled, monitored, and closed within acceptable timelines, escalating delays as necessary. /li liSupport continuous improvement, standardization, and site governance. /li /ul h3Your profile /h3 ul liExperience in CSV, validation, quality assurance, digital systems, automation, or computerized systems within a GxP-regulated environment (typically 4-7 years) /li liPractical experience with lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state /li liExperience supporting system users, coordinating stakeholders, or acting in a key-user, application-support, or system-governance role /li liGood working knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and recognized data integrity expectations, including PIC/S guidance /li liUnderstanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces, and computerized-system documentation /li liExperience with PLC/SCADA, industrial automation networks, particle monitoring or shared automation services /li liExperience with Active Directory, SIMATIC Logon, backup and restore, data transfer or infrastructure monitoring /li liExperience with digital checklist, workflow, electronic form or calculation-management solutions /li liExperience with data-flow mapping, data integrity risk assessments, access governance, metrics or inspection support /li liAcademic background: Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences, or a comparable technical or scientific discipline /li liEnglish fluent; Dutch is a strong plus /li liYou demonstrate the ability to translate business processes and paper-based activities into clear, controlled digital workflows and checklists, and to coordinate onboarding, testing, documentation, access governance, metrics, and timely record closure across multiple teams /li /ul h3What

we offer
/h3 pJoining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression. /p pIn practical terms, here’s what this means for you on a daily basis: /p pProjects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the bre