Senior Process Engineer - Technical Operations Science and Innovation (PT&D)
Location: Cheshire East
Job Type: Full time
Senior Process Engineer
Location: Macclesfield UK
Hybrid working policy, three days in office
Competitive salary and benefits apply
We have an exciting opportunity for a Senior Process Engineer to strengthen our team! In this role you will work within Technical Operations Science and Innovation (TOSI), a key function of our Pharmaceutical Technology & Development (PT&D) organization.
The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle.
TOSI is a multi-skilled Global organization based in 13 locations in 7 countries who provide the expert technical support for AstraZeneca commercial small molecule drug products, product robustness, manufacturing technology strategy and Packaging Development & Technology.
Underpinning the excellent technical support that drives robust product supply are technical processes & strategies around knowledge management, manufacturability, technical validation approaches, problem solving in alignment with the delivery of the technical inputs needed for fulfilling the Global Product Supply Strategy. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.
In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Now, more than ever, we’re progressing. Using leading-edge science and digital technologies, we’re driving automation and efficiency. Our vision of the ‘Smart Factory’ showcases us at our best. Disciplined thinkers and doers, we thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. A place where anyone is supported to step up and lead, and everyone has the freedom to take ownership and drive outcomes forward.
At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
The role of the Senior Process Engineer has the following responsibilities:
Responsible expert in pharmaceutical unit processes related to providing support at the process-equipment interface.
Provision of technical expertise & leadership to aid in the resolution of potential equipment related manufacturing issues & complaints impacting supply, including development of suitable corrective and preventive actions in support investigation
Provision of technical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion, new equipment etc) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
Responsible for the technical support during the transfer of established product manufacturing processes within sites and to external manufacturing partners. Including scale-up modelling, equipment selection and manufacturing engineering support.
Provision of technical expertise to propose and perform physical characterisation of raw materials, intermediates, and final products to support investigations, and drive changes and improvements related to drug product formulation and manufacturing process.
Identify opportunities for manufacturing improvement and lead the impact assessment & support technical improvements or major change activities assuring product performance, including provision of support for regulatory file authoring, review, license renewals and response to questions.
Drive standardisation & modernisation of manufacturing equipment across Operations, specific to regulatory expectation, good business practices, manufacturability and quality standards.
Required Skills & Knowledge
Have an understanding of the overall drug development and commercialization process from development, launch and through life cycle management.
Likely to be educated to BSc with ~3-5 years of relevant pharmaceutical industry experience post degree or PhD level with 2+ years of experience post degree in an appropriate discipline such as Chemical Engineering, Mechanical Engineering or similar discipline.
Have an understanding of a range of unit processes and equipment for OSD manufacturing (eg: mixing, drying, compression, roller compaction, coating, physical characterisation awareness, PSD, imaging etc)
Have experience of 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 Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
Evidence of good communication and relationship skills.
Preferred Skills & Knowledge
Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
Have previous experience and training in Lean and six sigma, problem solving tools.
Have experience in data analysis, interpretation, scale up, manufacturing engineering and digital twins/modelling.
Have experience in physical testing techniques of raw materials, intermediate and final drug products.
Have good leadership skills and behaviours with demonstration of being able to work across different functions.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.