Expert Système d'Information PAS/X (SME)

Responsibilities

• Drive the digital transformation of production lines by transitioning from paper-based to electronic batch records using PAS|X.
• Act as the Subject Matter Expert (SME) for PAS|X information systems, ensuring the development of innovative and transposable batch records.
• Define and approve quality documentation, including User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
• Manage MES projects through change control and local validation processes (cGMP).
• Write and execute test protocols in collaboration with SAP and Line Controller experts.
• Perform impact analyses for technical or personnel changes and lead troubleshooting efforts via Gemba walks.
• Support internal and global audits or regulatory inspections as the electronic batch record expert.
• Collaborate cross-functionally with Production, Supply Chain, and Quality departments to improve information systems.

Requirements

• Master's degree or equivalent experience in Information Systems.
• At least 5 years of professional experience in information systems, ideally within the pharmaceutical industry.
• Hands-on experience with Manufacturing Execution Systems (MES), specifically PAS|X or SIMATIC IT.
• Proficiency with SAP, TrakSYS, or Veeva.
• Experience with data visualization tools such as Power BI or QlikSense.
• Fluent English is mandatory for communicating with global colleagues and external providers.
• Strong organizational skills and the ability to manage shifting priorities in an operational environment.

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. Our Dunkerque site focuses on manufacturing treatments for respiratory diseases, investing heavily in digital transformation and sustainable production through programs like Everest and Maestria. We foster a vibrant, inclusive, and collaborative culture committed to scientific progress and patient care.