CAR-T Process Validation Engineer: CPV & Particle

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

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.