Junior Industrialisation Engineer

Close date: 31st January 2022

Job Title: Junior Industrialisation Engineer (Student Placement)

Position job holder reports to: Industrialisation Engineer

Position in Organisation: Please refer to the current version of the company organisation charts

Location: Unit 3, Enterprise 3930, Cambridge Research Park, Beach Drive, Waterbeach, Cambridge CB25 9PE.

Job purpose

  • Input to concept development phase of drug delivery devices to ensure suitability for commercial manufacturing.
  • Support the development and validation of manufacturing processes in support of Oval's novel drug delivery technologies. 
  • Support the Implementation of pharmaceutical and regulatory requirements within the industrialisation process.

Opportunity

This is an exciting and unique opportunity to join a small but growing company at an early stage, develop experience across a wide range of engineering and design activities and gain exposure to the structured process of medical device development.

Students will take a full and active role in our project teams and will have the opportunity to make significant contributions to the development phase of drug delivery devices to ensure suitability for commercial manufacturing.

Overview of Main Duties and Responsibilities

Key Responsibilities

  • Provide input to device design concepts from a manufacturing perspective.
  • Support the development team during concept and detailed design phases by;
    • Developing proof-of-principle processes for key manufacturing steps
    • Development of scalable manufacturing processes and techniques
    • Providing DFM input to the component design process to ensure robust manufacturing processes
  • Exposure to procurement of capital process equipment and tooling for pilot-scale manufacture including;
    • Generation of GMP standard Requirements Specifications
    • Contact with suppliers during the build phase
    • Writing and executing GMP standard FAT, SAT and IQ/OQ/PQ protocols (including mould tool validation)
    • Supporting the technical transfer and operation of equipment at its final location
  • Generation and communication of reports and presentations
  • Participate in risk analysis of processes including prioritisation and implementation of mitigations
  • Compliance with regulatory requirements, e.g. ISO13485, ISO 14971, cGMP, CFR210/211
  • Interfacing with potential users and customers as appropriate
  • Any other appropriate duties relevant to success of the company

Personal characteristics

  • Self-motivated and proactive nature
  • Creative
  • Open, honest, inclusive, personable
  • A team player with good interpersonal and communication skills
  • A desire to learn and a willingness to take on challenges

Experience/Skills needed to fulfill the role

  • Completion of 2 years of a recognised degree course in a relevant subject such as;
    • Mechanical Engineering
    • General Engineering
    • Chemical Engineering
    • Manufacturing Systems

Qualifications required

As per entry requirements for relevant degree courses.

Interface with other departments/communication internal & external

  • Liaise with all internal functions and personnel.
  • Present to appropriate business and technical audiences as necessary.
  • Some travel may be necessary as appropriate to project requirements.
Before continuing, please read what you need to submit in your application here.

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