Senior Engineer - Process Engineering & Packaging

Job Title: Senior Engineer - Process Engineering & Packaging

Location: Cambridge, UK

Salary: Competitive+ Excellent Employee Benefits!

About AstraZeneca:

At AstraZeneca, we harness the power of science to transform healthcare. Our mission is to treat, prevent, and cure complex diseases through innovation and collaboration.

Join a team that thrives on creativity and science-led decisions, continuously exploring new frontiers in medicine. With a commitment to cutting-edge technologies and smart risks, we are shaping the future of healthcare, one breakthrough at a time.

As part of our diverse and inclusive culture, youll contribute to meaningful work that reaches billions of patients globally. If youre driven by passion and purpose, join us at AstraZeneca and make a difference.

About the Role:

This role reports into the Process Engineering and Packaging (PEP) team for drug product process development within the Biopharmaceutical Development (BPD) function in AstraZeneca. The PEP team has accountability for drug product process development, process characterisation, combination product assembly development, and packaging science and technology across a broad range of biotech product types and technologies. We support the entire portfolio from Phase 1 clinical trial materials through to marketing application and product launch.

Typical Accountabilities:

Subject Matter Expertise

Drug Product Process Design and Development

Develop drug product manufacturing processes for vial, prefilled syringe and cartridge product

Perform process risk assessments such as FMEA, design characterisation and engineering studies, develop control strategies, author protocols, technical reports and regulatory filing sections

Specify requirements of manufacturing equipment and support equipment design and build

Provide technical rigor in design for manufacturing, experimental design, data analysis, and technical writing

Develop R&D laboratory process capabilities

Technology Transfer and Process Validation

Lead technology transfers to contract manufacturing organisations (CMOs) and internal manufacturing facilities for clinical and late-stage projects

Coordinate an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA

Ensure accurate implementation of control strategies for the drug product and device into manufacturing records

Design and lead all aspects of validation activities for equipment, manufacturing processes, and shipping. Lead timelines and activities internally, communicate goals and be responsible for successful delivery at the receiving site

Some travel in the EU and abroad is required in support of technology transfer

Technical Leadership

Supply critical thinking to drug and combination product development teams by providing knowledgeable advice on design for manufacturing, equipment vendor selection, manufacturing site selection / alternatives, project lead time and budget estimates

Advise functions and teams on new manufacturing technology selection and development

Develop risk-based characterization and validation strategies for manufacturing processes

Education, Qualifications, Skills and Experience

Essential Requirements:

Relevant technical degree (BSc, MSc, PhD, EngD) in Biochemical, chemical, or pharmaceutical engineering, or a related engineering or pharmaceutical science field.

Experience in Biopharmaceutical drug product development for monoclonal antibodies and recombinant proteins.

Experience of leading and delivering technology transfer of fill-finish processes.

Knowledge of formulation and fill-finish unit operations such as freeze-thaw, formulation, filtration, mixing, and aseptic filling.

Understanding and experience applying Quality by Design (QbD), experimental design and statistical data analysis.

Strong communication, influencing and relationship building skills with AZ customers, peers and third party suppliers.

Ability to develop and nurture innovation opportunities and lead any changes.

Desirable Requirements:

Knowledge of combination product development and cGMP regulations.

Knowledge of equipment, process and shipping validation.

Ability to work in diverse multinational teams.

Good awareness and understanding of current primary container and fill-finish technologies and the lifecycle approach to validation.

So, whats next?

Are you already envisioning yourself joining us? Good, because we cant wait to hear from you!

Welcome with your application; CV and cover letter, no later than April 4th.

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines.

More information about our sites:

Cambridge, UK

Gothenburg, Sweden

Gaithersburg, US

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.