Associate Principal Process Engineer

AstraZeneca•Mount Vernon, IN

About The Position

The Associate Principal Process Engineer will serve as a key authority in pharmaceutical unit operations, focusing on the mechanistic understanding of the process-equipment interface. This role provides advanced technical leadership and support by applying 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 lead technical support for transferring established product manufacturing processes internally and to external partners, employing scale-up modeling, equipment selection, and comprehensive manufacturing engineering support. They will also propose and implement physical characterization studies for raw materials, intermediates, and finished products to support investigations and drive improvements. This role involves finding opportunities for manufacturing improvement, leading impact assessments, and supporting the implementation of technical improvements or major change initiatives, including contributions to regulatory file authoring and responses to regulatory queries. A key aspect is driving the standardization and modernization of manufacturing equipment and processes across Operations, using advanced modeling and simulation to meet regulatory requirements and ensure manufacturability and quality standards.

Requirements

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, 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)
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.

Benefits

We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases.
At AstraZeneca, we’re dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.
To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
There is no better place to make a difference in medicine, patients, and society.
An inclusive culture where you will connect different thinking to generate new and valuable opportunities.
Where you will find a commitment to lifelong learning, growth and development for all.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We’re curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We’re driven to make the right choices and be accountable for our actions.
As an organisation centred around what makes us human, we put a big focus on people.
Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
And, together with your team, you’ll shape a culture that unites and inspires us every day.
This is your life at AstraZeneca.