Senior PAS-X (MES) Engineer – APICOM

This is a permanent position based at AstraZeneca’s innovative APICOM site in Dublin 15, supporting early/late‑stage API commercialisation through sophisticated digital manufacturing technologies.

Join AstraZeneca’s growing Digital OT team at APICOM, our global hub for small‑molecule API commercialisation. As the Senior PAS‑X (MES) Engineer, you will act as the site’s primary PAS‑X Subject Matter Expert, being responsible for the build, configuration, deployment, and continuous improvement of the Körber PAS‑X MES platform.

You will work at the heart of a highly digital, data‑driven manufacturing environment—partnering closely with Manufacturing, Quality, Automation, Engineering, IT and external vendors to deliver robust electronic batch execution and detailed system integrations. This role is critical in enabling right‑first‑time manufacturing, digital tech transfer, and inspection‑ready operations.

In this role, you will lead and sustain MES capabilities that underpin safe, compliant, and efficient API manufacturing. Key responsibilities include:

• Serve in the role of technical authority overseeing PAS‑X architecture, configuration standards, and lifecycle governance for the site.
• Develop and maintain modular eMBR templates, recipe structures, equipment models, alias/state management, and metadata.

• Own the design and configuration of electronic Master Batch Records aligned to ISA S88/S95.
• Embed IPCs, sampling plans, data capture, and electronic signatures to ensure full GMP compliance.

• Drive integrations between PAS‑X and SAP S/4HANA, DeltaV, Aveva PI, LIMS, and quality systems (Veeva/Kneat).
• Ensure data integrity, traceability, and alignment of master data across platforms.

• Lead UAT planning and execution, author test scripts, and support CSV activities in line with GAMP 5.
• Maintain validated state through structured change control, defect management, and documentation ownership.

• Serve as the contact for PAS‑X incidents, resolving system issues and guiding resolution of customer concerns.
• Monitor system performance and drive improvements to cycle time, right‑first‑time, and review‑by‑exception.

• Mentor end users and super‑users across manufacturing shifts.
• Champion digital adoption and contribute to building site MES capability.

• Lead PAS‑X workstreams for NPIs, digital tech transfer, upgrades, and ongoing initiatives focused on improvement.
• Coordinate external vendors including Körber, Infosys, SAP and automation partners.

• Significant experience with Körber PAS‑X, including PCS administration, eMBR authoring, equipment modelling, and site deployment.
• Strong understanding of small‑molecule API manufacturing, cGMP, batch execution, and QA expectations.
• Hands‑on experience integrating PAS‑X with SAP S/4HANA, DeltaV, Aveva PI and LIMS.
• Proficiency with ISA S88/S95 models.
• Strong CSV knowledge including URS/FRS/DS authoring, test scripting, UAT, and maintaining validated systems.
• Ability to translate business requirements into robust MES designs and influence multi-functional collaborators.
• Excellent communication, facilitation, and problem‑solving skills.

• Experience with PAS‑X upgrades, multi‑site template governance, and modular recipe libraries.
• Exposure to digital technology handover, analytics pipelines, and AI‑enabled MES use cases.
• SAP PP/MM master data alignment experience.
• Prior authorship of GMP documentation and training materials.
• Lean/Agile ways of working.

At AstraZeneca, we are driven by science, innovation, and a dedication to deliver life‑changing medicines. APICOM represents the next generation of digital manufacturing—where automation, MES, data, and AI converge to accelerate commercialisation and ensure flawless execution.

You’ll join a collaborative, forward‑thinking team where ideas are welcomed, development is encouraged, and your impact is felt across the entire supply chain.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.