Project Engineer Master Batch Records (MBR / MES)

Akkodis; Antwerpen; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Akkodis Belgium is seeking a Senior MES/ERP Specialist to design, validate and maintain Master Batch Records within the Siemens OpCenter Execution Pharma MES ecosystem. You will translate pharmaceutical production processes into robust master data, ensuring compliance with GMP and quality standards across MES, ERP and related databases.

You will collaborate with production, QA, IT and automation teams to define requirements, implement changes, and support continuous improvement while maintaining

Qualifications

• Master's degree in a scientific discipline or equivalent experience.
• Strong interest in MES/ERP systems and interfaces in regulated environments.
• Excellent analytical skills to translate complex workflows into robust Master Batch Records.
• Right-first-time mindset; accurate configurations, changes and documentation for MBRs.
• Proactive, independent planning and organizational skills with ability to meet deadlines.
• Willingness to participate in an on-call service with rotating schedule.
• Excellent Dutch and English, both written and spoken; strong communication with diverse stakeholders.
• Experience in regulated pharma/production environments is advantageous.
• Knowledge of SQL, Python, SCADA, PLC or related automation languages; familiarity with Lean/Six Sigma is beneficial.

Responsabilités

• Translate production processes into Master Batch Records and related master data, following quality standards.
• Design, install, test, document, and validate MBRs and master data across MES, ERP and databases.
• Collaborate with production and quality to define project requirements and timelines for new or modified lines and applications.
• Apply GMPs, SOPs and work instructions in MBR design and change activities.
• Lead or participate in quality improvement projects across site teams.
• Provide user support and training for MBRs, including occasional after-hours assistance.
• Coordinate with IT and automation to ensure proper integration of MBRs with MES/ERP systems.
• Manage smaller MBR changes within agreed deadlines with right-first-time execution.
• Maintain daily interdepartmental and occasional international contacts to align requirements.

Formation

Master's degree in a scientific discipline or equivalent

Outils

SQL

Python

SCADA

PLC

Lean Six Sigma

Description du poste

Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end-to-end project delivery. Driven by passion, expertise and impact, we make incredible happen.

In Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Our practices: Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.

Akkodis is part of the Adecco Group. You can find more information on our website : www.akkodis.com

You will work in the COMET Team, which is responsible for developing and maintaining Master Batch Records (MBRs) in the Siemens OpCenter Execution Pharma MES system. You will contribute to the design, installation, testing, documentation, and validation of new and updated MBRs and related master data across multiple computer systems, including MES, ERP, and databases. The position involves close collaboration with production, quality, IT, and automation teams, and requires strict adherence to pharmaceutical quality and compliance standards.

Your responsibilities

• Translate pharmaceutical production processes into Master Batch Records and related master data while strictly following pharmaceutical procedures and applicable quality standards.
• Design, install, test, document, and validate new and modified Master Batch Records and associated master data in MES, ERP, and database systems for diverse operational units.
• Collaborate regularly with production and quality supervision to define requirements and timelines for projects involving new or modified production lines, integrated applications, or stricter regulatory and quality requirements.
• Apply and respect Quality Standards, Current Good Manufacturing Practices, Standard Operating Procedures, and Work Instructions in all Master Batch Record design and change activities.
• Lead and participate in improvement projects related to quality, actively contributing within project teams, operational teams, and system teams across the site.
• Provide user support for your Master Batch Records, including training, guidance, and occasional assistance outside normal office hours to ensure continuity of operations.
• Work closely with IT and automation departments to ensure correct technical integration of MBRs with MES, ERP, and related computer systems and interfaces.
• Manage smaller but critical changes to Master Batch Records within agreed, sometimes short, deadlines while maintaining right-first-time execution and documentation.
• Maintain daily interdepartmental contacts and occasional international contacts to align on requirements, resolve issues, and ensure consistent implementation of MBR-related processes.

What skills do you bring to the table?

• Master's degree in a scientific discipline or equivalent experience, providing a strong foundation in pharmaceutical production and scientific processes.
• Demonstrated interest in MES/ERP systems and their interfaces, with clear affinity for working with computer systems in a regulated environment.
• Strong analytical skills with the ability to understand complex pharmaceutical production workflows and scientific processes and translate them into robust Master Batch Records.
• Ability to work accurately with a right-first-time mindset, ensuring that all configurations, changes, and documentation for MBRs and master data are correct and compliant.
• Hands-on working style with initiative, strong planning and organizational skills, and the ability to work independently within agreed timelines and priorities.
• Willingness to participate in an on-call service with a rotating schedule, including occasional support outside office hours, in line with role requirements and compensation.
• Excellent knowledge of Dutch and English, both spoken and written, combined with strong communication and writing skills for effective interaction with diverse stakeholders.
• Beneficial experience in a comparable role or pharmaceutical or similar regulated industry, providing familiarity with production and quality environments and cross-functional teamwork.
• Advantageous knowledge of SQL, Python, SCADA, PLC, or other automation and programming languages, as well as familiarity with Lean – Six Sigma methodologies.

Our recruitment process

Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist.

Step 2: Interview (60 min) with a Business Manager.

Step 3: Interview (60 min) with the client.