Sterilisation Validation/ Biocompatibility Engineer
Title: Sterilisation Validation/ Biocompatibility Engineer
Duration: 12 months Fixed Term Contract Location: Galway/ Working from home
We are recruiting for an excellent opportunity on behalf of our client, a leading medical device company based in Galway. The successful candidate will be involved in building the organization in support of Sterility Assurance & Biocompatibility assessments for New Product Development and Site Transfers. In the Sterilization Validation & Biocompatibility Services Department, the focus is on product quality excellence and providing exemplary service to the business units it supports.
Main Responsibilities and Duties
* Support sterility assurance & biocompatibility activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites
* Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation
* Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards.
* Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes
* Support your projects in internal and external audits and in submission preparation, addressing any questions regarding these submissions
* Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
* Review systems and processes for optimization and troubleshooting.
* Adhere to all relevant site wide procedures and practices for Safety & GMP Requirements
* Degree (Level 8) qualification in relevant technical discipline e.g. Science or Engineering * 2-3 years' experience with Sterilisation Validation or Biocompatibility is desirable
* Excellent understanding of GMP and documentation required
* Dynamic team player with good communication skills
* Can work effectively and proactively as an individual or on cross functional teams