We are currenting hiring aSenior Scientist/ Engineer, Device and Product Performance for a Dublin based Life Science Client
Key responsibilities for this role include:
Provision of technical expertise to support the development of Injectable Combination Products.
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 external test facilities or manufacturing sites.
Execution within internal laboratories, and/or coordination of product characterization and engineering verification testing, method development and validation to support robust product understanding throughout device development.
Dealing with the client 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 GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™.
Responsible for following all EHS process and procedures.
The key requirements for this role are:
Minimum of Bachelor’s degree in Science /Engineering with a minimum of 4 years experience of working with drug products and devices in R&D or Technical Services groups.
Minimum of 2 years experience in working within a laboratory environment, including experience in Method Development and Validation within Combination Products.
Previous experience in supervision activities with external test facilities, including test method development, validation and transfer.
Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks.
Willingness to learn and open to alternative ideas and solutions. Well-developed communication skills to lead or facilitate effective discussions with key stakeholders.
Some travel will be required as part of this roles
Any applicant must have an existing work visa/ permit or EU passport to apply.
Call Ruth Holland on 087-7822 198 for more information.