Senior Process Engineer

AstraZeneca plc; Durham (NC); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

AstraZeneca plc is seeking a Senior Process Engineer to join the GPD Process Technology and Engineering Unit in Durham, NC, focusing on inhaled and/or oral solid dosage development. You will lead lab and pilot-scale work, drive process understanding, and advance digital tools across early through late-stage programs.

You will collaborate across functions to shape development strategies, manage CPPs and technology transfer, and contribute to robust, scalable manufacturing processes for long-term

Qualifikationen

• Bachelor's degree in a related discipline (e.g. Chemical Engineering, Chemistry, or related field) with 3+ years of industry experience.
• Experience in oral solid dose and/or inhaled drug product development is required.
• Experience across early to late stage development, tech transfer, scale-up and process validation is highly preferred.
• Fundamental understanding of control strategy and risk management.
• Basic understanding of predictive science, AI, modelling and simulation.
• Demonstrated use of digital tools and process models for development.
• Excellent communication and collaboration skills.

Aufgaben

• Lead engineering work packages focused on designing and developing robust manufacturing processes for oral and inhaled products.
• Plan and execute lab-scale process development experiments to generate insights for key decisions.
• Shape product development direction through strong process understanding and control.
• Define and optimize CPPs and integrate them into control strategies.
• Lead or contribute to tech transfer, risk assessment, process validation, and scale-up activities.
• Apply modelling, simulation, digital twins, and predictive tools to strengthen understanding and speed up development.
• Identify and solve complex technical challenges impacting project delivery.
• Foster creativity, innovation, collaboration, and scientific excellence.

Kenntnisse

Process engineering

Oral solid dose

Inhaled products

Technology transfer

Process validation

Modeling & simulation

Digital tools

Risk management

Communication

Ausbildung

Bachelor's degree in Chemical Engineering

Jobbeschreibung

We are seeking a Senior Process Engineer to join our GPD Process Technology and Engineering Unit, supporting the development of innovative inhaled and/or oral solid dosage products.

In this role, you will lead key process engineering activities across an exciting portfolio of programs spanning early through late-stage development. As part of a multidisciplinary team, you will help shape product development strategies, design and execute laboratory and pilot-scale work packages, and advance the use of in silico tools to accelerate development and strengthen process understanding.

We are looking for a collaborative, solutions-focused engineer who thrives in a fast-paced scientific environment. You will play an important role in developing robust, well-understood, and well-controlled manufacturing processes designed to support long-term commercial performance and patient needs.

Key Responsibilities

• Lead engineering work packages focused on the design and development of robust manufacturing processes for oral and inhaled products.
• Plan and execute lab-scale process development experiments to generate insights and inform key project decisions.
• Help shape the scientific and technical direction of product development through strong process understanding and control.
• Define and optimize critical process parameters (CPPs) and integrate them into effective control strategies.
• Lead or contribute to technology transfer, risk assessment, process validation, and scale-up activities.
• Apply modelling, simulation, digital twins, and predictive tools to strengthen process understanding and accelerate development.
• Identify and solve complex technical challenges that directly impact project delivery.
• Champion a culture of creativity, innovation, collaboration, and scientific excellence.
• Partner across functions and take ownership of technical work packages, contributing to integrated drug product development plans within a multidisciplinary team and under the guidance of senior staff.

Essential Skills and Experience

• Bachelors Degree in Related Discipline (e.g - Chemical Engineering, Chemistry, or related field) with at least 3 years of relevant industry experience
• Experience in oral solid dose and/or inhaled drug product development.
• Experience in early to late stage product development, technology transfer, scale up and process validation.
• Fundamental understanding of control strategy and risk management.
• Basic understanding of predictive science, artificial intelligence, modelling and simulation.
• Demonstrated understanding and application of digital tools and process models for development
• Excellent communication and collaboration skills

Desirable Skills and Experience

• Masters or PhD in related discipline
• Experience with manufacturing processes and technologies relevant to oral solid dosage and/or inhaled products

• Direct compression/wet granulation/roller compaction tableting
• Spray drying particle engineering
• pMDI or DPI manufacturing

• Experience with regulatory authoring and defense.
• Experience with CMOs/CROs and outsourced development.
• Experience with regulatory submission authoring
• Process modelling / Digital twin development

Date Posted

16-Oct-2026

Closing Date

30-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.