Associate Principal Process Engineer
AstraZenecaAbout the role
Key Accountabilities
The role of the Associate Principal Process Engineer has the following responsibilities:
Serve as a key authority 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.
Find 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, employing advanced modelling and simulation to meet regulatory requirements, support good business practices, and ensure manufacturability and quality standards.
Required Skills & Knowledge
A minimum of a bachelor's degree or master's degree in Process/Chemical Engineering with a minimum of 5 + years of relevant pharmaceutical industry experience post degree, OR a PhD level with 3+ years of experience post degree
Demonstrate an understanding of the overall drug development and commercialization process from development, launch, and through life cycle management.
Demonstrate an understanding of a range of unit processes and equipment for OSD manufacturing (e.g. mixing, drying, compression, roller compaction, continuous direct compression,
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