API Process Senior Specialist

Location: College Park, Dublin

Full Time, Permanent

Introduction to Role:

Join us as an API Process Engineer and be part of a team that ensures the APICOM (Active Pharmaceutical Ingredient Commercialization) facility is safe, efficient, and capable of fulfilling its role within the AstraZeneca network of being a new product launch facility. You will play a critical role in accelerating scale up and technical transfers, collaborating with research and development, influencing plant operations, and reducing manual data handling as the facility becomes an industry leading paperless, automated, manufacturing environment. A strong background in process manufacturing of small molecule APIs is expected, along with the ability to collaborate effectively with both internal and external stakeholders and senior management. The technologies to be used for clinical and commercial manufacturing involve batch and continuous manufacturing as well as PAT and smart batch release.

Accountabilities:

As a small molecule API Process Senior Specialist, your primary focus will be on Cleaning Validation and/or Verification, for all equipment in direct contact with raw materials or products in the manufacturing process. You will also provide first-line technical support to the APICOM manufacturing teams by managing local changes and problem-solving production issues through correct use of problem tools. You will ensure compliance with current SHE (Safety, Health and Environment) and GMP (Good Manufacturing Practices) standards.

Essential Skills/Experience:

- Commercial or clinical scale manufacturing experience of small molecule API

- Degree level or equivalent in a relevant scientific or engineering discipline

- Problem-solving experience and skills

- GMP awareness

- Process safety awareness

Desirable Skills/Experience:

- Project experience

- Technical and/or engineering capabilities

- Data-driven approach to evaluate process performance for problem-solving and optimization

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, Operations is about getting more medicines to patients quickly, affordably, and sustainably. We leverage technology to deliver internally and externally, transforming our ways of working. We create smart factories that help us run better and make AstraZeneca a better place to work. Here, data is used to improve our processes and deliver better for people in need. A diverse, multigenerational workforce, we are united by our curiosity, we share learnings and scale fast.

Join us and play an integral part in realizing our purpose: delivering life-changing medicines. It's by being digitally-enabled that we can make a bigger impact and contribution to society, the planet, and our business. Feel the backing and investment of our leaders as we accelerate our Digital journey forward.

Ready to make a difference? Apply now!

Date Posted

01-Dec-2025

Closing Date

13-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.

API Process Senior Specialist

Job Description