Validation Engineer CSV - W/M/X

Amaris Consulting; Geel; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking a Validation Engineer – Computerized Systems to plan, execute and maintain validation activities for cGMP‑critical software in a regulated environment, ensuring systems stay validated and compliant.

You will work across QA, IT, engineering and business stakeholders, prepare validation documentation, and provide hands‑on validation execution and issue resolution. Strong English and Dutch skills are required.

Qualifications

• 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).

Responsabilités

• Plan, execute and maintain validation activities for cGMP‑critical software in a GMP environment.
• Prepare validation documentation (protocols and reports) and support hands‑on execution.
• Ensure validation documents are reviewed, approved and implemented, maintaining validated state.
• Validate systems per industry standards in line with cGMP, cGLP and internal procedures.
• Ensure projects comply with Sanofi procedures and regulatory standards.
• Stay current on validation regulations and provide input on US FDA and EU requirements.
• Assess changes for impact on validated status and define validation needs.
• Investigate and troubleshoot validation issues and implement corrective actions.

Connaissances

GxP compliance

Validation experience

Software validation

Troubleshooting

Independent work

Stakeholder communication

English & Dutch

Description du poste

Job Description

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

Your missions

• 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.

Your profile

• 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).

What We Offer

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.

Who are we?

Amaris Consulting 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.

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!