Job description
Mission
Lead the digitalization of paper batch records by implementing and validating Siemens Opcenter Execution Pharma (formerly SIMATIC IT eBR). You will configure, test, and qualify the system to ensure seamless electronic batch record deployment across global manufacturing sites.
Key Responsibilities
* Design – create and configure Process Instructions (PI) in Opcenter to replicate existing paper batch records.
* Test Design – build test PIs within the Global MES Test environment to verify functionality and data integrity.
* Validation – execute Design Qualification (DQ) and Operational Qualification (OQ) test scripts, document evidence, and resolve deviations.
* Collaboration – work with process engineers, QA, and IT to align digital workflows with cGMP and site SOPs.
* Documentation – author and maintain functional specs, test protocols, traceability matrices, and validation reports.
Must-Have
* 4–6 years configuring or validating Siemens Opcenter (SIMATIC IT eBR) in pharma/biotech.
* Solid understanding of ISA-88, GAMP5, and 21 CFR Part 11.
* Hands-on experience with PI design, recipe authoring, and electronic signature workflows.
* Proven track record executing DQ/OQ protocols and managing validation deviations.
* Fluent in French and English is mandatory (technical writing & verbal).
Nice-to-Have
* Experience with ERP (SAP) integration and MES roll-outs across multiple sites.
* Knowledge of SQL, XML, or scripting for data mapping and interface testing.
* Additional European languages.
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.