Assoc. Principal Process Engineer experienced in Pharmaceutical Operations

We have a great opportunity for an Associate Principal Process Engineer to strengthen our team! In this role you will work within Technical Operations Science and Innovation (TOSI), a key function of our Pharmaceutical Technology & Development (PT&D) organization.

The PT&D Organization, within AstraZeneca Operations, is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle.

TOSI is a multi-skilled Global organization provide the expert technical support for AstraZeneca commercial small molecule drug products, product robustness, manufacturing technology strategy and Packaging Development & Technology.

Underpinning the excellent technical support that drives robust product supply are technical processes & strategies around knowledge management, manufacturability, technical validation approaches, problem solving in alignment with the delivery of the technical inputs needed for fulfilling the Global Product Supply Strategy. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Now, more than ever, we’re progressing. Using leading-edge science and digital technologies, we’re driving automation and efficiency. Our vision of the ‘Smart Factory’ showcases us at our best. Disciplined problem solvers and doers, we thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. A place where anyone is supported to step up and lead, and everyone has the freedom to take ownership and drive outcomes forward.

At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

Key Accountabilities

The role of the Associate Principal Process Engineer has the following responsibilities:

• Serve as a key expert in pharmaceutical unit operations with a focus on the mechanistic understanding of process-equipment interface, providing advanced technical leadership and support.
• Apply process engineering principles to identify, develop and use modelling and simulation tools for predicting process performance, resolving operational issues, and optimising both equipment function and system integration.
• Provide technical leadership and expertise in resolving complex process-related manufacturing issues, utilising core engineering modelling and simulation to resolve complex manufacturing challenges and enhance process efficiency.
• Contribute to product supply strategy projects, including sourcing, asset transfers, capacity expansions, and the introduction of new equipment.
• Lead technical support for the transfer of established product manufacturing processes within internal manufacturing sites and to external partners, employing scale-up modelling, equipment selection, and comprehensive manufacturing engineering support.
• Propose and implement physical characterisation studies for raw materials, intermediates, and finished products to support investigations and drive improvements in formulation and manufacturing processes.
• Identify opportunities for manufacturing improvement, lead impact assessments, and support the implementation of technical improvements or major change initiatives with a focus on maintaining product performance, including contributions to regulatory file authoring, license renewals, and responses to regulatory queries, supported by model-based risk assessments.
• Drive the standardisation and modernisation of manufacturing equipment and processes across Operations, using advanced modelling and simulation to meet regulatory requirements, support good business practices, and ensure manufacturability and quality standards.

Essential requirements

• Demonstrate an understanding of the overall drug development and commercialization process from development, launch, and through life-cycle management.
• Process/chemical Engineering BSc/MSc with a few years of relevant pharmaceutical industry experience post degree or PhD level with work experience post degree
• Demonstrate an understanding of a range of unit processes and equipment for OSD manufacturing (e.g. mixing, drying, compression, roller compaction, continuous direct compression, coating) and awareness of physical characterisation of raw material, intermediate and final products (e.g. mechanical testing, particle size distribution, imaging etc).
• Experience in process scale up, manufacturing engineering and digital twins/modelling
• Experience in data analysis/data science languages and the use of digital tools.
• Experience with a range of CMC elements related to commercial product manufacturing process requirements – e.g., process establishment, optimisation and validation, control of drug products, stability, packaging and commercial manufacturing, with good understanding of SHE and cGMP.
• Experience in Pharmaceutical Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organisation.
• Evidence of good communication and relationship skills.

Desirable requirements

• Experience in or exposure to multiple subject areas in CMC and related functions (e.g. Product Development, Operations, Global Supply, Marketing Companies)
• Have previous experience and training in Lean and Six Sigma, problem solving tools.
• Have experience in physical testing techniques of raw materials, intermediate and final drug products.
• Experience in or exposure to coding and programming languages.

At AstraZeneca, we 're dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. We have an inclusive culture that fosters diversity and collaboration and are committed to lifelong learning, growth and development.

Are you ready to bring new ideas and fresh thinking to the table? Excellent!

Please apply with your CV and cover letter. We welcome your application no later than September 4th, 2025!

Date Posted

20-aug.-2025

Closing Date

03-sep.-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.