Sterilisation Validation/ Biocompatibility Engineer

15 Mar 2021
12 Apr 2021
Megan Power
Job Type

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

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