Senior CSV Engineer

Senior CSV Engineer - College Park, Dublin

This is a permanent position based at AstraZeneca’s new innovative plant dedicated to API production in Dublin.

Introduction to role

Join AstraZeneca at a pivotal moment as we build a next‑generation API manufacturing facility developed to accelerate commercial product launches and set new standards for digital, sustainable manufacturing.

Taking on the position of expert CSV Engineer, you will help build how GxP-relevant automation and digital systems are developed. You will also validate and maintain these systems within a highly automated, data-rich Smart Factory environment. You will ensure regulatory compliance, inspection readiness, and long‑term system operability while enabling efficient delivery of a modern, digitally‑enabled manufacturing site.

We offer a rare greenfield opportunity to define validation standards, governance, and lifecycle ownership for automation and digital systems that will underpin future API manufacturing across the AstraZeneca network.

Accountabilities

In this role, you will provide technical leadership across Computer System Validation (CSV), ensuring that all GxP‑relevant automation, IT/OT, and digital systems are developed, implemented, and operated in line with regulatory expectations and industry standard process.

Your responsibilities will include:

CSV Leadership

• Lead validation and assurance activities for all GxP‑relevant automation and digital systems.
• Define and maintain a robust CSV framework aligned with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5.
• Ensure validation strategies are risk‑based, defensible, and aligned with intended use and patient impact.

Greenfield Project Delivery

• Act as CSV Lead during the design, build, commissioning, and start‑up of the new API facility.
• Embed GxP, information accuracy, and lifecycle considerations into system build and configuration from the beginning.
• Review and approve vendor documentation to support right‑first‑time qualification and inspection readiness.

Automation & Coordination between Information Technology and Operational Technology

• Support the definition and implementation of compliant IT/OT architectures.
• Ensure secure data flows, appropriate access control, and data integrity across computerized and electronic systems.
• Collaborate with Engineering, Automation, Quality, and Process Technology teams to ensure systems support Smart Factory objectives.

Governance & Partner Engagement

• Act as the primary point of accountability for CSV across project and operational phases.
• Establish effective governance, risk assessment, and escalation pathways.
• Communicate progress, risks, and compliance strategies to internal and external partners.

Transition to Operations

• Own the transition of validated systems into routine operations.
• Define lifecycle processes for change control, periodic review, incident management, and requalification.
• Ensure systems remain compliant, performant, and fit for purpose throughout their lifecycle.

Continuous Improvement

• Drive simplification, standardisation, and digitalisation of validation practices.
• Contribute to the development of site standards, procedures, and training related to automation alongside CSV activities.

Essential Skills & Experience

• Degree or equivalent experience in Engineering, Computer Science, Automation, or related technical field.
• Significant experience delivering CSV for automation and manufacturing systems in regulated pharmaceutical environments.
• Shown experience supporting capital projects and facility start‑ups, ideally within API manufacturing.
• Solid understanding of GMP, data integrity, and regulatory expectations (EU GMP Annex 11, 21 CFR Part 11, GAMP 5).
• Ability to influence across Engineering, Quality, Process Technology, and Operations.
• Comfortable working in sophisticated, fast‑paced environments with evolving priorities.

Desirable Skills & Experience

• Experience in highly automated or digitally enabled manufacturing environments.
• Exposure to IT/OT integration and data‑centric manufacturing systems.
• Experience supporting inspection readiness and regulatory interactions.
• Track record of continuous improvement in validation or compliance practices.

Why AstraZeneca?

At AstraZeneca, we are driven by innovation and a dedication to deliver life‑changing medicines. With a brand‑new facility, innovative automation, and a digital‑first demeanor, there has never been a more exciting time to join our manufacturing organisation. We develop a culture where ideas are welcomed, teamwork is encouraged, and people are empowered to make an impact.

If you’re motivated by challenge, excited by greenfield opportunities, and passionate about shaping the future of pharmaceutical manufacturing, this is the role for you.

Ready to build the next era of digital manufacturing? Apply now.

Date Posted

17-Feb-2026

Closing Date

16-Feb-2026

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.