Associate Principal Process Engineer

Key Accountabilities

The role of theAssociate PrincipalProcess Engineerhas the following responsibilities:

• Serve as a key authority in pharmaceutical unit operations with a focus on themechanistic understanding ofprocess-equipment interface, providing advanced technical leadership and support. 

• Apply process engineering principles toidentify,developand use modelling and simulation tools for predicting process performance, resolving operational issues, and optimising both equipment function and system integration.

• Provide technical leadership andexpertisein resolving complexprocess-related manufacturing issues, utilisingcoreengineeringmodellingand simulation toresolve complex manufacturing challenges and enhance process efficiency.

• Contribute to product supply strategy projects, including sourcing, asset transfers, capacity expansions, andtheintroduction of new equipment.

• Lead technical support for the transfer of established product manufacturing processes within internal manufacturing sites and to external partners, employing scale-upmodelling, equipment selection, and comprehensive manufacturing engineering support.

• Propose and implement physical characterisation studies for raw materials, intermediates, and finished productsto 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 onmaintainingproduct 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,employingadvancedmodellingand simulation to meet regulatory requirements, support good business practices, and ensure manufacturability and quality standards.

Required Skills & Knowledge

• A minimum of abachelor'sdegree or master's degree in Process/Chemical Engineeringwitha minimum of 5+years of relevant pharmaceutical industry experience post degree, ORaPhDlevel with3+ years of experience post degree 

• Demonstrate an understanding of the overall drug development and commercialization process from development, launch, and through life cycle management.

• Demonstratean understanding of a range of unit processes and equipmentfor OSD manufacturing (e.g.mixing, drying, compression,roller compaction,continuousdirect compression,coating) andawareness ofphysical characterisationof rawmaterial,intermediateand final products(e.g.mechanical testing,PSD,imagingetc).

• Haveexperience inprocessscale up, manufacturing engineering and digital twins/modelling

• Haveexperience in dataanalysis/data science languages and theuse of digital tools.

• Have experiencewitha range of CMC elements related to commercial productmanufacturing processrequirements – e.g., process establishment,optimisationand validation, control of drug products, stability,packagingand commercial manufacturing, with good understanding of SHE and cGMP.

• Experience inPharmaceuticalOperations and/or R&D witha track recordof successful project leadership and delivery within a matrix organisation. 

• Evidence ofgoodcommunicationand relationshipskills.

Preferred Skills & Knowledge

• Experience in or exposure to multiple disciplines in CMC and related functions (e.g.Product Development, Operations, Global Supply, Marketing Companies)

• Havepreviousexperience and training in Lean andSixSigma, problem solving tools.

• Have experience in physicaltestingtechniquesof raw materials,intermediateandfinal drug products.

• Experience in or exposure to coding and programming languages.