Remote Validation Engineer

Il y a 2 semaines

Geel, Antwerpen, Belgique Amaris Consulting Temps plein 55 000 € - 85 000 € Contrat

Gratuit avec email ou Google

Enregistrez cette offre et organisez votre recherche

Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.

Enregistrer le travail Enregistrer et créer une alerte

Gratuit avec email ou Google

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

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

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.

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 h

Remote Validation Engineer

Enregistrez cette offre et organisez votre recherche

Emplois similaires à Geel

Offres similaires

Amériques

Europe

Asie / Océanie

Afrique

Remote Validation Engineer

Enregistrez cette offre et organisez votre recherche

Emplois similaires à Geel

Offres similaires