AstraZeneca

Senior Engineer - Process Engineering & Packaging

Location
Cambridgeshire, Cambridge, England
Salary
Negotiable
Posted
28 Jan 2021
Closes
25 Feb 2021
Ref
R-099017
Contact
AstraZeneca
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Senior Engineer - Process Engineering & Packaging

Cambridge, UK

Salary & Benefits Competitive

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality!

Job Description

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

  • 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

  • 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, what's next?

Are you already envisioning yourself joining us? Good, because we can't wait to hear from you!

Welcome with your application; CV and cover letter, no later than 28th February 2021.

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:

Covid-19 Resources

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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.