Job Title: Senior Process EngineerLocation: MacclesfieldSalary: Competitive
A Senior Process Engineer role at AstraZeneca offers the chance to combine engineering expertise with cutting‑edge science to develop and scale up sustainable drug substance manufacturing processes. Working in our Particle Science & Process Engineering team within Pharmaceutical Sciences, this position focuses on introducing new equipment and technologies into our Large Scale Lab and driving robust, efficient and environmentally responsible processes for clinical and preclinical supply.
New Technology Introduction
- Responsible for the safe and GMP‑compliant introduction of new equipment into the kilo lab facilities, from design through to installation and commissioning.
- Lead interactions and design activities with the large‑scale laboratory chemistry and engineering teams, and equipment vendors, considering facility interfaces, maintenance requirements, installation requirements and FAT/SAT strategy.
- Collaborate with QA colleagues to develop the commissioning and qualification strategy of new equipment including the authoring of User Requirements Specification, Design Qualification and IQ/OQ documentation.
- Perform process and operational hazard identification and risk assessments (e.g. HAZOP) and define mitigation strategies throughout the project’s lifecycle.
- Establish SOPs, guidance documents and training materials for safe, efficient operation. Mentor users and ensure efficient hand over to operational and maintenance teams.
- Implement process control strategies, PAT and data acquisition; integrate with site digital systems as appropriate for traceability and tech transfer.
- Act as change control owner for the documentation of Safety and GMP compliant actions.
Process Development
- Provide engineering expertise to the development and optimisation of chemical processes, including laboratory experimentation, modelling and simulation and assessment and communication of the results obtained.
- Work closely with our Contract Manufacturing Organisations (CMOs) across the globe, providing process engineering input into process development and accommodation into manufacturing facilities.
- Carry out scale‑up manufacturability assessments of processes to ensure right first‑time scale‑up, technical transfer and future viability.
- Drive learning from manufacturing and deliver process improvements for subsequent manufacturing campaigns.
- Solve problems arising during the manufacture or process development.
- Champion and drive sustainability of processes with respect to environmental sustainability, efficiency and cost.
- Develop external contacts (industrial and academic) to bring learning and innovative process engineering science into AstraZeneca.
- Lead novel science and technology projects, applying engineering knowledge to develop core understanding of the subject area(s) and to assess future scale‑up and technology needs.
Essential Skills and Experience
- A PhD in Chemical Engineering, or a bachelor’s or master’s degree in Chemical Engineering or Biochemical Engineering with at least three years of experience working in the Pharmaceutical or Fine Chemicals industry or similar.
- Hands on experience of carrying out laboratory experimentation unit operations such as mixing, distillation, liquid‑liquid extraction, crystallisation, tangential flow filtration, coprecipitation, isolation and drying and evaluating their dependency on scale and equipment through the use of risk assessments and modelling.
- Hands on experience of introducing process equipment and technology within existing facilities.
- Proven experience of using structured problem solving tools.
- Strong collaborative and communication skills.
- Experience working on a highly regulated environment.
- Demonstrable experience of applying principles of Safety, Health and Environment (SHE) regulations and Good Manufacturing Practice (GMP) to chemical manufacturing processes, including running change controls in manufacturing facilities.
Desirable Skills and Experience
- Experience of equipment commissioning and validation practices.
- Experience of chemical or process development, scale up and / or technical transfer.
- Experience of working across skillsets (e.g. chemists, analysts, formulators, statisticians).
- Ability to use modelling software (e.g. Aspen, DynoChem, Computational Fluid Dynamics) to support process understanding.
- Experience of working with CDMOs.
- Familiarity with the process of running HAZOPs.
- Ability to mentor junior colleagues (graduates, placement students, apprentices).
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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