Assoc. Principal Process Engineer experienced in Pharmaceutical Operations

<p>We have a great opportunity for an <b>Associate Principal Process Engineer </b>to strengthen our team! In this role you will work within <b>Technical Operations Science and Innovation</b> (TOSI), a key function of our Pharmaceutical Technology &amp; Development (PT&amp;D) organization.</p><p></p><p>The PT&amp;D Organization, within AstraZeneca Operations, is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle.</p><p></p><p>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 &amp; Technology.</p><p>Underpinning the excellent technical support that drives robust product supply are technical processes &amp; 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.</p><p></p><p>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.</p><p></p><p>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.</p><p></p><h2><b>Key Accountabilities</b></h2><p>The role of the <b>Associate Principal Process Engineer</b> has the following responsibilities:</p><ul><li>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.</li><li>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.</li><li>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.</li><li>Contribute to product supply strategy projects, including sourcing, asset transfers, capacity expansions, and the introduction of new equipment.</li><li>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.</li><li>Propose and implement physical characterisation studies for raw materials, intermediates, and finished products to support investigations and drive improvements in formulation and manufacturing processes.</li><li>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.</li><li>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.</li></ul><p></p><h2><b>Essential requirements</b></h2><ul><li>Demonstrate an understanding of the overall drug development and commercialization process from development, launch, and through life-cycle management.</li><li>Process/chemical Engineering BSc/MSc with a few years of relevant pharmaceutical industry experience post degree or PhD level with work experience post degree</li><li>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).</li><li>Experience in process scale up, manufacturing engineering