Senior Process Engineer

AstraZeneca • Mount Vernon, IN

1d

About The Position

The Associate Principal Process Engineer role serves as a key authority in pharmaceutical unit operations, focusing on the mechanistic understanding of the process-equipment interface and providing advanced technical leadership and support. This role applies process engineering principles to identify, develop, and utilize modeling and simulation tools for predicting process performance, resolving operational issues, and optimizing both equipment function and system integration. The engineer will provide technical leadership and expertise in resolving complex process-related manufacturing issues, utilizing core engineering modeling and simulation to address challenges and enhance process efficiency. Contributions will be made to product supply strategy projects, including sourcing, asset transfers, capacity expansions, and the introduction of new equipment. The role also involves leading technical support for the transfer of established product manufacturing processes within internal manufacturing sites and to external partners, employing scale-up modeling, equipment selection, and comprehensive manufacturing engineering support. Additionally, the engineer will propose and implement physical characterization studies for raw materials, intermediates, and finished products to support investigations and drive improvements in formulation and manufacturing processes. Opportunities for manufacturing improvement will be identified, impact assessments led, and technical improvements or major change initiatives supported, with a focus on maintaining product performance. This includes contributions to regulatory file authoring, license renewals, and responses to regulatory queries, supported by model-based risk assessments. The role drives the standardization and modernization of manufacturing equipment and processes across Operations, employing advanced modeling and simulation to meet regulatory requirements, support good business practices, and ensure manufacturability and quality standards.

Requirements

• A minimum of a bachelor's degree in Process/Chemical Engineering with a minimum of 5 + years of relevant pharmaceutical industry experience.
• 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, coating) and awareness of physical characterisation of raw material, intermediate and final products (e.g. mechanical testing, PSD, imaging etc).
• Have experience in process scale up, manufacturing engineering and digital twins/modelling.
• Have experience in data analysis/data science languages and the use of digital tools.
• 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 relationship 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)
• Master's Degree or PhD with a minimum of 3 years relevant experience
• 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.

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.

What This Job Offers

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