Senior Scientist/ Engineer: Device and Product Performance
- BBBH815831 May 13, 2022 Competitive
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.
- 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.
- 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.
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Manager | Engineering Recruitment
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