As a Validation Engineer – Computerized Systems, you will be responsible for planning, executing and maintaining validation activities for cGMP‑critical software packages and computerized systems. You will ensure systems remain in a validated state, compliant with cGMP, regulatory expectations and internal procedures, directly supporting reliable and compliant manufacturing and laboratory operations
- Develop, implement and execute validation activities (URS, SIA, DQ, IQ, OQ, PQ, RV, TM) for computerized systems in a cGMP environment.
- Prepare validation documentation (protocols and reports) and support/perform hands‑on execution of validation protocols.
- Ensure validation documentation is properly reviewed, approved and implemented, maintaining systems in a validated state at all times.
- Perform validation of systems with existing industry precedence, interpreting standards for the specific case in line with cGMP, cGLP and internal procedures.
- Ensure projects are managed in compliance with Sanofi procedures and applicable cGMP and regulatory standards.
- Stay current on emerging validation regulations and practices; provide technical input on US FDA and EU requirements.
- Assess changes for impact on validated status and validation documentation, and define required validation activities.
- Investigate and troubleshoot validation issues, proposing and implementing appropriate corrective actions.
- Minimum 3 years of experience in the pharmaceutical sector and GMP environment.
- Solid knowledge of Computer Systems Validation and relevant quality/compliance regulations (e.g. GxP, data integrity, FDA/EU guidelines).
- Experience validating software packages and computerized systems, from planning to execution and documentation.
- Strong troubleshooting skills for validation and system issues.
- Able to work independently, learn quickly and execute projects according to plan.
- Strong communication skills, able to interact with QA, IT, engineering and business stakeholders.
- Good command of English and Dutch (spoken and written).
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 discuss the full benefits breakdown during our meetings.
Amaris Consulting 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.
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Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 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!
