Manufaturing Systems Specialist

A global biopharmaceutical leader committed to delivering innovative therapies and solutions that improve patient lives. The organisation operates in a highly regulated environment, ensuring compliance and excellence across manufacturing, packaging, and IT systems.

As an Packaging Execution Systems Specialist, you will provide technical leadership and manage projects for Manufacturing Execution Systems (Koerber PAS|X) and integration with Product Serialization Systems (Systech), ERP (SAP), SCADA (Rockwell), and other automation interfaces. This role supports commercial and clinical labelling and packaging operations in a GMP-regulated environment.

• Deliver initiatives and oversee support tasks for MES and Packaging Execution Platforms.
• Manage lifecycle of MES and related automation systems.
• Analyse, design, and implement new requirements and site expansion initiatives.
• Ensure systems comply with regulatory standards (FDA cGxP, 21 CFR Part 11) and corporate policies.
• Act as point of contact for applications and related infrastructure.
• Perform configuration, testing, and documentation for system changes.
• Provide training and mentorship to team members.
• Collaborate with cross-functional teams to optimise operations and develop business solutions.
• Maintain SOPs and ensure readiness for audits and inspections.

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or Life Sciences.
• Minimum 6 years’ experience in MES and Packaging Execution Systems.
• Proven experience with Koerber PAS|X, Systech Serialization, and SCADA systems.
• Strong knowledge of GMP-regulated environments and compliance frameworks.
• Experience with automation systems, OPC interfaces, and IT/OT integration.
• Familiarity with SQL, Oracle, Unix/Linux.
• Excellent communication and problem-solving skills.
• Fluent in English; willing to work on-call outside office hours.

Ready to take on a key technical role in a global biopharma environment? Apply with your most recent CV!