Principal Process Engineer

AstraZeneca • Mount Vernon, IN

6d

About The Position

The Principal Process Engineer will serve as a skill area leader for pharmaceutical unit operations, focusing on the mechanistic understanding of the process-equipment interface. This role involves leading technical strategic initiatives, networks, and forums within the organization related to pharmaceutical manufacturing processes and equipment. The engineer will execute technical leadership and influence across Operations, applying process engineering principles to identify opportunities, develop, and deploy reduced-order mechanistic and physics-informed process models. These models, based on first-principles engineering and equipment geometry (e.g., mass, energy, and momentum balances), will be used to predict process performance, resolve operational issues, support scale-up, and optimize equipment and system integration. The role also provides technical leadership in resolving complex manufacturing challenges, contributing to product supply strategy projects, and leading technical support for process transfers. A key aspect is identifying manufacturing improvement opportunities, leading impact assessments, and supporting the implementation of technical improvements, including contributions to regulatory documentation. The Principal Process Engineer will drive the standardization and modernization of manufacturing equipment and processes, leveraging advanced modeling and simulation to meet regulatory requirements and ensure quality standards.

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 7+ years of relevant pharmaceutical industry experience post degree or PhD level with 5+ years of experience post degree
• Demonstrate an understanding of pharmaceutical product End-to-End Control Strategy (CS) and/or Enhanced Control Strategy (ECS).
• Have demonstrated experience in the development and application of reduced-order mechanistic and physics-informed models of pharmaceutical unit operations and equipment (e.g. mixing, drying, compression, roller compaction, continuous direct compression and coating), including models derived from equipment geometry and first-principles engineering relationships such as mass and energy balances.
• Demonstrate an understanding of physical characterisation of raw material, intermediate and final products and impact on manufacturing process robustness (e.g. mechanical testing, PSD, imaging etc).
• Have experience in scientific programming, data analysis and digital tools used to develop, implement and maintain mechanistic and hybrid (physics-informed) process models.
• Have 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 leadership skills.

Nice To Haves

• Experience in or exposure to multiple disciplines 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, Agile application.
• Have experience in physical testing techniques of raw materials, intermediate and final drug products.
• Experience in or exposure to coding and programming languages.

Responsibilities

• Serve as skill area leader for pharmaceutical unit operations with a focus on the mechanistic understanding of process-equipment interface.
• Lead of technical strategic initiatives, networks or forums within the organization related to pharmaceutical manufacturing processes and equipment.
• Executing Technical Leadership and influencing across Operations.
• Apply process engineering principles to identify opportunities for, develop and deploy reduced-order mechanistic and physics-informed process models based on first-principles engineering and equipment geometry (e.g. mass, energy and momentum balances) to predict process performance, resolve operational issues, support scale-up and optimise equipment and system integration.
• Provide technical leadership and expertise in resolving complex manufacturing challenges through the application of first-principles engineering analysis, mechanistic modelling and simulation, developing fit-for-purpose reduced-order models to identify root causes, assess risks and improve process performance.
• 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.
• 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, leveraging advanced modelling and simulation to meet regulatory requirements, support good business practices, and ensure manufacturability and quality standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal