MES Specialist - APICOM

Job Title: MES Specialist

Location: APICOM Facility, College Park, Dublin, Ireland

Competitive Salary and Benefits

Company Overview:

AstraZeneca is a global biopharmaceutical leader focused on the development of Active Pharmaceutical Ingredients (API) using cutting-edge technologies. Our Dublin API Commercialisation facility is a state-of-the-art hub designed to transition novel small-molecule therapies from development to commercial manufacturing. We leverage advanced digital solutions to drive efficiency, compliance, quality and innovation.

Job Summary:

We are seeking a highly skilled MES Specialist to support the design, authoring, testing, and optimisation of Manufacturing Execution System (MES) recipes and electronic Master Batch Records (eMBRs) using Körber PAS-X and DeltaV platforms. This role is critical to ensuring compliant, efficient, and robust manufacturing operations aligned with GMP standards and digital transformation goals.

Accountabilities:

Recipe Authoring & MES Development

• Create and maintain electronic Master Batch Records (eMBRs) using PAS-X.
• Design PAS-X master batch recipes and DeltaV phases/operations aligned with S88 standards.
• Ensure modularity, reuse, and compliance in recipe structures.
• Integrate IPCs, checkpoints, sampling plans, and electronic signatures for GMP-compliant eMBRs.
• Maintain recipe versions and associated metadata (PD/PV/PVL/long text).
• Support DeltaV design and recipe modifications for New Product Introductions (NPIs).
• Align automation systems with cGMP and GAMP best practices.

2. Process & Equipment Mapping

• Collaborate with Process Technology to ensure recipe fit with site capabilities.
• Map recipe steps to equipment models and physical assets using DeltaV and PAS-X.
• Confirm control module functionality and equipment model alignment.

3. Material & BOM Integration

• Map raw materials and products to S4/HANA material masters.
• Link BOMs and recipes to production versions in S4/HANA and PAS-X.

4. Simulation, Testing & Validation

• Participate in recipe dry runs and simulations using PAS-X, DeltaV, and Mimic.
• Validate sequencing, transitions, and timings.
• Fine-tune operations based on review of test results.
• Support Computer Systems Validation (CSV) activities and documentation.

5. Change Management & Documentation

• Participate in recipe change control processes using Veeva and Kneat.
• Maintain version control and audit trails.
• Document recipe logic, structure, and business rules.
• Maintain SOPs, work instructions, and training materials.

6. Training & Support

• Train end-users on PAS-X and DeltaV systems.
• Support handover to Manufacturing and provide ongoing MES issue resolution.
• Champion MES adoption across manufacturing shifts.

7. Digital Tech Transfer & Data Alignment

• Ensure consistent data across PAS-X, DeltaV, LIMS, and S4/HANA.
• Link recipe data to batch records, material traceability, and analytics.
• Collaborate with the Chemical Development department to transfer process information from the pilot plant into APICOM using the Digital Tech Transfer application, ensuring alignment with PAS-X and DeltaV recipe structures and site capabilities.

Essential Skills/Experience:

• 2 years or more experience of working in Synthetic Drug Substance (or API) Manufacturing Operations.
• Knowledge of Pharmaceutical manufacturing processes, procedures and equipment within a Synthetic Drug Substance (or API) Substance environment.
• Lean manufacturing and optimisation mindset.
• Willingness to widen knowledge of manufacturing processes.
• Experience of process mapping in a manufacturing environment.
• Comprehensive understanding of cGMP requirements for commercial pharmaceutical manufacturing.
• Good interpersonal skills are required, as is the ability to communicate well, both verbally and within written documents.
• Experience of use of Korber PAS-X.

Desirable Skills/Experience:

• Experience of change management in a complex environment.
• Understanding manufacturing computer systems and eData Integrity requirements.
• Experience of developing or supporting the lifecycle of Electronic Batch Records.
• Knowledge of S/4 HANA and DeltaV (For EBR configuration)

At AstraZeneca, we are driven by a patient-focused ethos that inspires us to innovate and create meaningful value. Our culture is rooted in integrity, inclusiveness, and dedication to supporting the communities we serve. Here, diversity and different thinking are valued, empowering us to explore new ideas that profoundly impact patients' lives. With a rapidly expanding portfolio, we offer an entrepreneurial spirit combined with the strength and resources of a global biopharma. Join us in making a difference where it truly counts!

Ready to embark on this exciting journey? Apply now and be part of a team that is transforming lives!

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Date Posted

18-Nov-2025

Closing Date

08-Dec-2025

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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.