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

Job Description
Join 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. In 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. Your missions
• Provide 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).
• Review and approve validation deliverables, including assessments, plans, requirements, risk assessments, specifications, test documentation, traceability, and summary reports.
• Assess changes, incidents, deviations, defects, and CAPAs for impact on product quality, patient safety, data integrity, and validated state.
• Apply a pragmatic, risk-based approach focused on critical functions, data, interfaces, and controls.
• Assess controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention, and data transfer.
• Support data-flow mapping, inspection readiness, periodic reviews, and escalate material quality risks as needed.
• Coordinate and oversee the creation, configuration, testing, and documentation of new digital checklists in Checklyst Manager.
• Ensure new or changed checklists are reviewed, tested, approved, and released before operational use.
• Onboard new areas and teams, align on intended use, responsibilities, training, and readiness for adoption.
• Govern user access, support timely provisioning, modification, and removal of access, and periodically review roles and responsibilities within the system.
• Provide first-line functional guidance to users, authors, reviewers, and area representatives, and coordinate escalation of system issues.
• Run and review system and process metrics, identify overdue or non-compliant records, and coordinate follow-up actions.
• Ensure records are controlled, monitored, and closed within acceptable timelines, escalating delays as necessary.
• Support continuous improvement, standardization, and site governance.

Your profile
• Experience in CSV, validation, quality assurance, digital systems, automation, or computerized systems within a GxP-regulated environment (typically 4-7 years)
• Practical experience with lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state
• Experience supporting system users, coordinating stakeholders, or acting in a key-user, application-support, or system-governance role
• Good 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
• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces, and computerized-system documentation
• Experience with PLC/SCADA, industrial automation networks, particle monitoring or shared automation services
• Experience with Active Directory, SIMATIC Logon, backup and restore, data transfer or infrastructure monitoring
• Experience with digital checklist, workflow, electronic form or calculation-management solutions
• Experience with data-flow mapping, data integrity risk assessments, access governance, metrics or inspection support
• Academic background: Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences, or a comparable technical or scientific discipline
• English fluent; Dutch is a strong plus
• You 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

What we offer
Joining 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. In practical terms, here’s what this means for you on a daily basis: 🎯 Projects 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 breadth. 🤝 Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts. 🚀 A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged. 💡 Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact. 🌱 CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together. 👉 Health insurance, remote work, meal vouchers, time savings account, referral bonus… We’ll talk about our full benefits package during our interviews. Mantu is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. Who are we? Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. At Amaris, We Strive To Provide Our Candidates With The Best Possible Recruitment Experience. We Like To Get To Know Our Candidates, Challenge Them, And Be Able To Give Them Proper Feedback As Quickly As Possible. Here's What Our Recruitment Process Looks Like Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you Interviews (the average number of interviews is 3
- the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. We look forward to meeting you