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MES Expert Pharmaceuticals [F/M/X]Amaris Consulting • Belgium
MES Expert Pharmaceuticals [F / M / X]
Amaris Consulting • Belgium
9 dagen geleden
FunctieomschrijvingLead 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. 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. 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).
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
Required Qualifications
Preferred Skills
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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