
Scientific Validation Specialist
2 weeks ago
Validation Scientist Job
To help support our growing company, we now seek a permanent full-time Validation Scientist to perform the studies required for domestic and international regulatory submissions.
We are a global molecular diagnostics company driving improved patient outcomes using our innovative technology to provide configurable clinically relevant molecular diagnostic solutions for infectious diseases. We support leading pathology laboratories around the world with a keen focus on meeting our customer needs.
This is an excellent opportunity to join our team as a Validation Scientist where you will:
- Perform analytical studies for new nucleic acid extraction kits and real-time PCR assays
- Assist with some aspects of process, equipment, and computer software validation
- Analyze data and assist with problem-solving and experimental design
- Prepare study protocols and reports
- Maintain meticulous documentation for all tasks as required by our Quality Management System
- Evaluate compliance with project management principles
To succeed as a Validation Scientist, you should have:
- A minimum of a BSc in Biomedical Science or a related field
- Previous experience in an assay development or validation role for medical devices or other regulated products
- Previous experience with product or process or equipment validation
- Molecular biology experience including Real-time PCR
- Strong problem-solving and analytical skills
- A flexible and adaptable attitude
- Excellent time management and organizational skills
The Ideal Candidate
- Experience in assay validation in compliance with TGA/FDA or EU regulations
- Computer software validation experience
- Ability to independently source technical information, formulate hypotheses, design experiments, and interpret results
- Experience in compliance with principles of ISO 13485
- Familiarity with the regulated environment and experience in undertaking controlled studies to support regulatory submissions
What We Offer
A competitive remuneration package commensurate with your experience
You will be part of a dynamic team dedicated to improving healthcare outcomes
Join us in making a difference to healthcare in communities around the world
Apply NowSubmit your application online along with your CV
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We value diversity and equal opportunities
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