MES Expert: Master Batch Record & PAS-X Migration

Amaris Consulting; Puurs-Sint-Amands; Hybride; EUR 60 000 - 85 000; 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 Medior MES Expert in Belgium to lead the migration of Master Batch Records and MES functionalities to PAS-X, while ensuring GxP compliance and data integrity. You will design MBRs, validate MES processes, and collaborate with cross-functional teams in a regulated Life Sciences setting.

You will coordinate validation activities, support change management, and train end-users while working with stakeholders acrossOrange, Sanofi, and other major accounts.

Qualifications

• Minimum 3 years of relevant experience in pharma/biotech/life sciences manufacturing.
• Experience supporting implementation or migration of regulated computerized systems.
• Experience with requirements gathering, business process analysis, and fit-gap assessments.
• Experience writing or reviewing SOPs and procedural documentation.
• Strong stakeholder management and communication skills.
• Experience with MES, LIMS, QMS, SAP-based solutions.
• Knowledge of data migration and master data concepts is an asset.
• Experience in Computer System Validation within a GxP-regulated environment is considered an asset.

Responsabilités

• Master Batch Record (MBR) Design & Review: Ensure efficient migration of current MBRs and MES functionalities to PAS-X, review master recipes for GxP compliance and alignment with validation files, support data harmonization, and approve MBR designs from a quality perspective.
• Business Process Analysis & Requirements Management: Document and analyze existing manufacturing processes, support process mapping and future-state design, gather and formalize business and user requirements, assist in preparing specifications, and ensure traceability throughout the validation lifecycle.
• Project & Stakeholder Management: Work within a cross-functional project team, contribute to planning and execution, participate in meetings and workshops, proactively communicate risks and progress, and support change control activities.
• Testing & System Implementation: Prepare and execute validation and user acceptance testing, coordinate testing with stakeholders, document results and deviations, and verify that implemented solutions meet business and compliance requirements.
• Change Management & Training: Support the deployment and adoption of new systems and processes, create and update documentation (SOPs, work instructions), develop and deliver training, and assist operational teams during implementation and hyper-care phases.

Connaissances

MES Experience

GxP Knowledge

Stakeholder Management

Requirements Gathering

Business Process Analysis

Change Management

SOP Documentation

Training Delivery

Outils

LIMS

QMS

SAP

Description du poste

Amaris Consulting is seeking a Medior MES Expert in Belgium to lead the migration of Master Batch Records and MES functionalities to PAS-X, while ensuring GxP compliance and data integrity. You will design MBRs, validate MES processes, and collaborate with cross-functional teams in a regulated Life Sciences setting.

You will coordinate validation activities, support change management, and train end-users while working with stakeholders acrossOrange, Sanofi, and other major accounts.