QA MES PAS-X (F/H/X)

Amaris Consulting | Part of Mantu; Beerse; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a QA Project Engineer MES to support compliant electronic master batch records for CAR‑T manufacturing sites in Ghent and Beerse. You will QA verification activities, review MBR docs, and ensure GMP and data‑integrity across projects.

Join a team collaborating with MES experts, QA Operations, Manufacturing, IT, and project groups. You’ll work in English and Dutch, maintain thorough documentation, and drive continuous improvement in a global, client‑facing environment.

Qualifications

• Bachelor’s or Master’s degree in bio-engineering, pharmacy, life sciences, or a related field.
• 4 to 6 years of professional experience, incl. at least 3 years in GMP/pharma.
• Practical QA activities in pharmaceutical manufacturing.
• Good knowledge of cGMP requirements and pharma regulations.
• Experience with MES systems (PAS-X or Opstracker).
• Fluent in English and Dutch.

Responsibilities

• Provide QA oversight for electronic MBR verification activities.
• Review MBR checklists, design docs, testing strategies, and protocols.
• Review verification protocols and supporting evidence.
• Document comments and ensure timely closure of actions.
• Review traceability matrices, PQ docs, and go-live docs.
• Support QA and data-integrity reviews of PAS-X master data and MES elements.
• Ensure deliverables meet GMP, data‑integrity, and internal procedures.
• Identify risks, deviations, test observations, and corrective actions.
• Support preparation and review of quality/validation docs.
• Update stakeholders with clear info and timely escalations.
• Maintain inspection-ready documentation and pursue continuous improvement.

Skills

QA activities

cGMP knowledge

MES systems

PAS-X

Opstracker

English

Dutch

Education

Bachelor’s or Master’s degree in bio‑engineering, pharmacy, life sciences, or related field

Tools

PAS-X

Opstracker

Job description

Job Description

As a QA Project Engineer MES, you'll support the delivery of compliant electronic master batch records for CAR-T manufacturing sites in Ghent and cryopreservation and Quality Control activities in Beerse.

You’ll work within the QA MES team and collaborate with MES technical experts, QA Operations, Manufacturing, IT, and project teams. Your role will focus on reviewing verification documentation, ensuring GMP and data-integrity requirements are met, and keeping QA deliverables on track from planning through completion.

Your missions

• Provide QA oversight for electronic master batch record verification activities, in line with approved procedures, timelines, and priorities.
• Review MBR checklists, Design Documentation Specifications, testing strategies, and test protocols.
• Review executed verification protocols and supporting evidence.
• Document comments, follow up on their resolution, and ensure that actions are closed properly.
• Review traceability matrices, Performance Qualification documentation, project quality plans, summary reports, and go-live documentation.
• Support QA and data-integrity reviews of PAS-X master data, electronic batch records, and other MES elements.
• Confirm that project deliverables meet GMP, data-integrity, and internal procedural requirements.
• Identify and follow up on risks, deviations, test observations, and corrective actions.
• Support the preparation and review of quality and validation documentation.
• Keep project stakeholders informed through clear updates and timely escalation.
• Maintain complete, accurate, and inspection-ready documentation.
• Contribute to continuous improvement within the QA MES team.
• Work closely with international colleagues and stakeholders in English and Dutch.

Your profile

• Bachelor’s or master’s degree in bio‑engineering, pharmacy, life sciences, or another relevant technical or scientific field.
• 4 to 6 years of professional experience, including at least 3 years in the pharmaceutical industry or another GMP-regulated environment.
• Practical experience with QA activities in pharmaceutical manufacturing.
• Good knowledge of cGMP requirements and relevant pharmaceutical regulations.
• Experience with master batch records in a GMP production environment.
• Experience reviewing MBR verification, qualification, or validation documentation.
• Experience with MES production systems, ideally PAS-X or Opstracker.
• Fluent in English and Dutch.

What we offer

Joining Amaris means working in an environment where your performance supports your career progression.

Projects with substance

Our projects last 18 months on average and involve major accounts such as Orange, Sanofi, SNCF, and CMA-CGM. You'll work on assignments where your experience has a direct impact on project delivery and product quality.

Support from your manager and HR

Each manager supports up to 18 consultants. You'll have regular project check-ins and a direct exchange with HR every month through Express Yourself. Our teams have an average tenure of 3.3 years.

Career progression

70% of our managers started in entry‑level positions. Career development is based on skills, performance, and the opportunities you take. Functional mobility across 4 areas of expertise and international mobility across 60+ countries are actively encouraged.

Learning and technology

You'll have access to 250+ training modules, fully funded Microsoft certifications, and 291 AI agents developed in-house. We support continuous learning throughout your career.

Social and environmental commitments

Our commitments include an SBTi carbon reduction roadmap, a target of 34.3% women in management by 2029, and social engagement through We Care Together.

Health insurance, remote work, meal vouchers, a time savings account, and a referral bonus are also available. We'll discuss the full benefits package during the recruitment process.

Amaris Consulting is proud to be an equal‑opportunity workplace. We’re committed to building a diverse and inclusive working environment. We welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.

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.

Recruitment process

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!