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Senior Scientist/ Engineer: Device and Product Performance

Job Seekers Ireland Science Life Science

Job Summary

  • Dublin
  • Permanent
  • BBBH815831
  • May 13, 2022
  • Competitive
Job Description

This is a unique and very exciting opportunity to join a global R&D center of excellence. This site supports the development of Biological, Respiratory and Injectable Combination Products.

Responsibilities

  • Provision of technical expertise to support the development for Biological, Respiratory and Injectable Combination Products.
  • Lead and provide technical support to a team responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.
  • Providing technical mentorship to more junior members of the injectables team, including guidance for technical issues and review/approval of documents.
  • Leading the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.
  • Dealing with company affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations.
  • Responsible for testing of pre-filled syringes, pen injectors and potentially other devices within the Global Device Development portfolio (for example, Auto-Injectors), including generation of protocols, oversight of execution of testing at external test facilities and writing of reports.
  • Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.
  • Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.
  • Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance's and the latest regulatory and industry thinking.
  • Lead and review device investigations and participate in technical investigation teams as required. Reporting and logging of aberrant results using Trackwise
  • Responsible for following all EHS process and procedures.

Requirements:

  • Bachelor's degree in Science/Engineering with a minimum of 4 years drug product/device experience in R&D or Technical Services groups.
  • Experienced in supervision activities with internal/external test facilities, including test method development, validation and transfer.
  • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife Duggan
Aoife Duggan
  • Manager | Engineering Recruitment
  • +353 21 2300300
  • aduggan@morganmckinley.com