AstraZeneca

Principal Process Engineer

AstraZeneca • $110K — $130K *
Mount Vernon, IN 47620In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BSc/MSc in Process or Chemical Engineering; 7+ years in pharmaceuticals or PhD with 5+ years.
  • Understanding of drug development, manufacturing, and commercialization processes.
  • Experience in mechanistic modeling and process optimization specific to pharmaceutical unit operations.
  • Familiarity with End-to-End Control and Enhanced Control Strategies for pharmaceutical products.
  • Proficient in scientific programming, data analysis, and digital tools for model maintenance.
  • Experience with CMC elements including drug product stability, packaging, and cGMP compliance.
  • Strong communication and leadership abilities for matrix project management.

Responsibilities

  • Lead technical initiatives pertaining to pharmaceutical manufacturing processes and equipment.
  • Develop mechanistic models to enhance process performance and system integration.
  • Provide technical leadership to resolve complex manufacturing challenges using first-principles analysis.
  • Support product supply strategy projects including asset transfers and equipment introduction.
  • Oversee the transfer of established manufacturing processes to internal and external partners.
  • Identify and implement manufacturing improvements while ensuring compliance with regulatory standards.
  • Drive modernization and standardization of manufacturing operations through advanced modeling techniques.

Benefits

  • Opportunity to lead and influence in a pivotal engineering role within pharmaceutical manufacturing.
  • Engagement with cross-disciplinary teams and diverse project types.
  • Potential for professional growth in a dynamic and innovative environment.
  • Involvement in strategic decision-making processes affecting product supply.
  • Exposure to the latest modeling tools and techniques in the industry.
Full Job Description
Key Accountabilities

The role of the Principal Process Engineer has the following 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.


Required Skills & Knowledge
  • 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.


Preferred Skills & Knowledge
  • 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.


Date Posted
11-Sep-2026

Closing Date
01-Oct-2026

About AstraZeneca

AstraZeneca is a British-Swedish multinational pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs. The company was formed in 1999 through the merger of Astra AB and Zeneca Group plc. AstraZeneca's products are used to treat a wide range of medical conditions, including cancer, cardiovascular disease, respiratory disease, and diabetes. The company has operations in over 100 countries and employs more than 76,000 people worldwide. AstraZeneca is committed to developing innovative medicines that improve the health and well-being of people around the world.
Learn more about AstraZeneca
Size
83,100 employees
Market Cap
$211.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.1 billion
Founded
1999
5 Year Trend
+10.2%
Revenue
$26.6 billion
NASDAQ
AZN
* Ladders Estimates

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