QA MES Project Engineer (PAS-X) – GMP & Data Integrity

MANTU GROUP SA; Belgique; Hybrid; EUR 70,000 - 90,000; 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 in Ghent and QA activities in Beerse. You will collaborate with MES experts, QA Operations, Manufacturing, IT and project teams to ensure GMP compliance and data integrity from planning through delivery.

Ideal candidates hold a relevant degree and 4–6 years of experience in the pharmaceutical sector, with hands-on work in MBR verification and MES systems.

Qualifications

• Bachelor’s or Master’s degree in bio-engineering, pharmacy, life sciences or related field.
• Experience with QA activities in GMP-regulated environments and pharmaceutical manufacturing.

Responsibilities

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

Skills

QA oversight

cGMP knowledge

MBR verification

MES systems

PAS-X / Opstracker

English & Dutch

Education

Bachelor’s or Master’s degree in bioscience or related field

Tools

PAS-X

Opstracker

Job description

Amaris Consulting is seeking a QA Project Engineer MES to support compliant electronic master batch records for CAR-T manufacturing in Ghent and QA activities in Beerse. You will collaborate with MES experts, QA Operations, Manufacturing, IT and project teams to ensure GMP compliance and data integrity from planning through delivery.

Ideal candidates hold a relevant degree and 4–6 years of experience in the pharmaceutical sector, with hands-on work in MBR verification and MES systems.