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Product Development Engineer

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Date: Sep 15, 2022

Location: Larne Millbrook, GB

Company: Terumo BCT, Inc.

PRODUCT DEVELOPMENT SCIENTIST/ENGINEER

 (Ref No:  22-26)

PRODUCT DEVELOPMENT SCIENTIST/ENGINEER

 (Ref No:  22-26)

 

A vacancy currently exists for a Product Development Scientist/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. 

 

(Salary: £Negotiable / dependent upon experience)

 

Duties will include:

  • Leading the development of new solutions: partner with process engineering to develop manufacturing process feasibility; determination of specifications for finished goods/stability and analytical test methods; determine acceptance criteria, resolve issues with specifications found during feasibility.
  • Accountable for introduction and evaluation of new analytical methods to analyze raw materials and/or finished products – including drug substance and bag components
  • Leading product development transfer activities, including the successful transfer into manufacturing by partnering with process engineering and production.
  • Perform statistical analysis and present conclusions to supervisor, project leader and management
  • Support Regulatory Affairs submission packages for a variety of regulatory bodies.
  • Write, review and approve product documentation utilizing an electronic document management system.
  • 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:

  • Minimum 3 years' experience gained within the pharmaceutical or medical device industry - similar highly regulated industry will be considered.
  • BSc (or equivalent) in Engineering or Science discipline; or equivalent industrial experience within the medical device or pharmaceutical industry.

 

Desirable Criteria:

  • Ability to lead and manage projects Product Technical Transfer experience
  • Experience in analytical techniques (e.g. HPLC, AA, UV, FTIR, ICP-OES and GC etc.)
  • Knowledge of steam and/or other sterilization methods
  • 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 MySource before the closing date of 5pm Friday 30th September 2022    

If you would like to apply for this vacancy, please apply via MySource before the closing date of 5pm Friday 30th September 2022    


Job Segment: Medical Device Engineer, Product Development, Pharmaceutical, Process Engineer, Medical Device, Engineering, Research, Science, Healthcare