Medical Device Specialist

2 days ago

Donegal, Donegal, Ireland beBeeScientist Full time €65,888 - €98,435

Job Overview

Technical Support Scientist Role

We are seeking a skilled and experienced Technical Support Scientist to join our team. As a key member of our organization, you will be responsible for providing technical support and guidance to ensure the successful delivery of complex technical projects.

Responsibilities
  • Plan, implement and lead technical projects, including validation activities and product/process improvements.
  • Support the development and roll out of technical trials/characterization studies.
  • Contribute to analytical development through design and execution of experiments, data analysis and communication of conclusions.
  • Coordinate and contribute to the design of SOPs, test methods, protocols, specifications and validation documentation.
  • Plan, implement & lead analytical method transfers, optimization, and validation.
  • Execute experiments; participate in experimental design and utilize DOE where appropriate.
  • Participate in the planning and execution of raw material, components, and vendor qualification or alternate supplier analytical qualification studies.
  • Provide analytical testing support for manufacturing process validation.
  • Seek opportunities for significant process or product improvements.
Requirements
  • A Bachelor of Science degree or higher in a relevant Chemistry, Physics or Life Science discipline.
  • Knowledge of good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs.
  • Experience and knowledge of analytical chemistry is a distinct advantage i.e. HPLC and UV-Vis, GC, FTIR and Dissolution apparatus.
  • Experience and knowledge of Analytical validation and method transfers is a distinct advantage.
  • Self-motivated and significant project experience with an ability to influence others are essential.
  • Excellent communication / interpersonal skills.
  • A minimum of 2 years experience in medical device industry is required.

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