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MES Expert Pharmaceuticals [F/M/X]
MES Expert Pharmaceuticals [F/M/X]Amaris Consulting • Belgium
MES Expert Pharmaceuticals [F / M / X]

MES Expert Pharmaceuticals [F / M / X]

Amaris Consulting • Belgium
8 dagen geleden
Functieomschrijving

Job description

MES project :

  • System upgrade
  • Limited reprogramming (scope defined, focused on critical changes)
  • Full validation lifecycle (including test protocol development, execution, reporting, and post-upgrade monitoring)
  • No formal training provided on the new version candidates must be self-sufficient and experienced.

Key Responsibilities

  • Lead and execute the end-to-end validation process for the Siemens Opcenter upgrade :
  • Develop and finalize test protocols (using existing templates).
  • Perform protocol reviews and approvals with stakeholders.
  • Execute test cases and track results in real time.
  • Document and report findings, including defects, deviations, and resolution status .
  • Prepare final validation summary report and support regulatory readiness.
  • Support system upgrade activities (preparation, migration, post-upgrade verification).
  • Collaborate with IT and automation teams to ensure seamless integration and data integrity.
  • Conduct post-upgrade monitoring for at least 2 months to validate long-term stability and performance.
  • Act as a subject matter expert (SME) in MES validation and CSV (Computer System Validation) practices.
  • Ensure compliance with GxP, ISO 13485, and EU Annex 11 standards where applicable.

    • Required Qualifications

  • Bachelor’s degree in Engineering (Electrical, Industrial, Automation, or IT), Computer Science, or related field.
  • Minimum 5 years of experience in MES systems , preferably with Siemens Opcenter (formerly Tecnomatix, Teamcenter, or similar) .
  • Mandatory FRENCH and ENGLISH fluent.
  • Proven experience in CSV and validation lifecycle management (IQ / OQ / PQ).
  • Strong understanding of MES data flows, interfaces, and integration points .
  • Experience with version upgrades of enterprise manufacturing systems (especially in regulated environments).
  • Proficiency in documentation, test case design, and defect tracking .
  • Ability to work autonomously with minimal supervision.
  • Excellent communication and stakeholder management skills.

    • Preferred Skills

  • Experience in automated manufacturing environments (pharma, medical devices, automotive, or high-tech manufacturing).
  • Familiarity with IT / automation project lifecycles and cross-functional collaboration.
  • Knowledge of data integrity principles and audit readiness .
  • Experience with Agile or structured project methodologies .
  • Willingness to work on-site during critical upgrade windows (e.g., summer shutdowns).

    • Why joining us?

    Rapid growth : Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

    Prestigious projects : Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

    International environment : An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

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