Process Validation Engineer (M/W/X)

Amaris Consulting; Oost-Vlaanderen; Sur place; EUR 70 000 - 90 000; 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 Process Validation Engineer to support CPV activities and particle governance within the CAR-T EMEA program. You will extract data from MES/LIMS/SAP, perform statistical analyses, and flag deviations to ensure cGMP compliance in a biotechnological setting.

The role emphasizes collaboration with QA, MSAT, and cross-functional teams, with opportunities to influence governance models and monitoring strategies across the CAR-T workflow.

Qualifications

• Experience in pharmaceutical/biotech, cell therapy, or related fields.
• Knowledge of GMP/cGMP and regulatory expectations.
• Experience in controlled cleanroom environments is a plus.
• Ability to manage multiple tasks and report progress.
• Fluency in Dutch and English.

Responsabilités

• Support CPV report generation by assisting lead engineers in data gathering, drafting sections, and routing annual Stage 3 CPV reports for approval
• Extract and structure manufacturing and analytical data from MES, LIMS, SAP for CAR-T metrics
• Perform routine data entry and initial statistical analysis (using JMP or Minitab) to monitor critical process parameters
• Identify process drift and flag out-of-trend data or process variations for further investigation
• Coordinate with QA and MSAT to track missing batch documentation and deviation updates
• Map particle monitoring across CAR-T manufacturing workflow, detailing sampling points and data flows
• Monitor and trend particulate data, investigate deviations and root causes
• Design future-state governance models to improve particle mitigation and handling protocols
• Present technical data and risk assessments to the Particle Governance Board for alignment

Connaissances

Dutch language

English language

Project management

Cross-functional teamwork

Problem solving

Formation

Bachelor’s degree or higher in engineering, biotech, biomedical sciences, or pharmacy

Outils

MES

LIMS

SAP

JMP

Minitab

Description du poste

Job Description

Join our Life Sciences team and contribute to the advancement of innovative cell therapy solutions in the CAR-T EMEA program. As a Process Validation Engineer (M/W/X), you will play a key role in supporting the continued process verification (CPV) and particle governance activities, ensuring the highest standards of quality and compliance in a cutting-edge biotechnological environment.

Your missions

• Support CPV report generation by assisting lead engineers in data gathering, drafting sections, and routing annual Stage 3 CPV reports for approval
• Extract and structure manufacturing and analytical data from electronic systems (MES, LIMS, SAP) for key CAR-T metrics
• Perform routine data entry and initial statistical analysis (using JMP or Minitab) to monitor critical process parameters and quality attributes
• Identify process drift and flag out-of-trend data or process variations for further investigation
• Coordinate with Quality Assurance and MSAT specialists to track missing batch documentation and deviation updates
• Map the current state of particle monitoring across the CAR-T manufacturing workflow, detailing sampling points, inspection methods, and data flows
• Monitor and trend historical and real-time particulate data, investigate deviations, and identify root causes
• Design future-state governance models to improve particle mitigation, including enhanced monitoring strategies and optimized handling protocols
• Present technical data, trending reports, risk assessments, and proposed frameworks to the Particle Governance Board for strategic alignment

Your profile

• Experience in the pharmaceutical, biotechnology, cell therapy, human plasma-derived products, or related industry
• Experience with introduction of pharmaceutical products to manufacturing sites and late-stage development with technical knowledge of manufacturing site unit operations
• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Experience working in a controlled, cleanroom environment under aseptic conditions is a plus
• Proficiency in project management, with the ability to provide timely and accurate reporting on project activities
• Ability to interact at different levels of the organization
• Ability to work under pressure, handle conflicting interests, and make decisions
• Ability to work independently under general direction, prioritize tasks, and manage time effectively
• Strong team player with problem-solving skills and attitude
• Dutch and English fluent
• Bachelor’s degree or higher in engineering, biotech, biomedical sciences, or pharmacy

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… Find the full benefits breakdown at our dedicated page.

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 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!