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Product Development Engineer

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Date: Jan 14, 2022

Location: Larne Millbrook, GB

Company: Terumo BCT, Inc.

PRODUCT DEVELOPMENT ENGINEER

 (Ref No:  22/01)

A vacancy currently exists for a Product Development Engineer within the Innovation and Development group. The successful candidate will be responsible for the development of new parenteral pharmaceutical solutions and support of existing solution products. 

 

 

Duties will include:

  • Leading the development of new solutions: partner with process engineering to development manufacturing process feasibility; determination of specifications for finished goods/stability and analytical test methods; determine acceptance criteria, resolve issues with specifications found during feasibility.
  • Leading product development transfer activities
  • Perform statistical analysis and present conclusions to supervisor, project leader and management
  • Support Regulatory Affairs submission packages for a variety of regulatory bodies.
  • Reviews and approve product documentation.
  • Contributes to the establishment of business objectives, goals, budgets and costs
  • Represent Terumo BCT with external customers to identify and decide on feasibility of proposed projects.
  • Translate international standards and local regulatory requirements into product requirements and working to ICH Quality guidelines for Stability and Validation.
  • Participate and/or lead, risk management activities including planning, identification of hazards, analysis and mitigation
  • Adhere to the quality system requirements, local procedures, ensure GMP standards; also, adhere to general and specific environmental, health and safety guidelines.
  • Understanding project timelines, strategy, deliverables and planning project work accordingly with departmental, functional and external stakeholders

 

Essential Criteria:

  • BSc (or equivalent) in Engineering or Science discipline
  • Minimum 3 years of experience in a similar highly regulated industry eg Pharmaceutical, medical Devices, Food.
  • Knowledge and experience of design controls
  • Understanding of and adherence to GMP practices and ISO Standards

 

Desirable Criteria:

  • Knowledge of steam and/or other sterilization methods
  • Ability to lead and manage projects Product Technical Transfer experience
  • Experience of method development, validation, verification and transfer, including creation of plans, protocols and reports.
  • Experience in supporting Regulatory Affairs submission packages for a variety of regulatory bodies

 

If you would like to apply for this vacancy, please apply via our internal careers website using the link below before the closing date of 5pm on Friday 28th January

Terumo BCT Ltd is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability, race or ethnic origin, nationality, sexual orientation or age.

 


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