Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Scientist / Sr Scientist (Medical Device) - Ware, UK
Thermo Fisher's clinical research business is a leading global contract research organization and a world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we provide a functional service provider solution, allowing our customers to leverage our staff's experience while giving employees the opportunity to gain direct onsite experience at pharmaceutical/biopharmaceutical companies, with full benefits.
Purpose:
This role supports project delivery within the Device Engineering team in the Drug Product Development Department at our client’s site in Ware.
Essential Functions:
- Perform medical device testing to Non-GMP and GMP standards.
- Support verification of medical device analytical methods, including validation, transfer, and equivalence studies.
- Develop medical device analytical methods.
- Conduct medical device investigations, including disassembly, visual inspection, and X-Ray or CT scans.
- Lead and contribute to internal self-inspection audits, communicate findings, and ensure corrective actions are completed.
- Assemble medical devices for testing and stability assessments.
- Support validation of laboratory equipment such as force testers, 3D printers, X-Ray devices, and manufacturing tools, ensuring registration and maintenance.
- Plan laboratory activities to ensure timely project delivery.
- Review and approve experimental reports.
Education and Experience:
- B.S./M.S. in Engineering, Analytical Science, Chemistry, Life Science, or related field, with 1-3 years of industry laboratory experience, preferably in pharmaceuticals.
Knowledge, Skills, and Abilities:
- Understanding of GMP and non-GMP analysis, data integrity, and GxP environments.
- Experience with analytical method validation and transfer.
- Proven ability to deliver projects within complex, multidisciplinary teams across organizational boundaries.
- Strong communication skills and self-motivation.
- Knowledge of medical device testing standards and ISO guidelines is advantageous.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you align with our values and want to contribute to delivering safe and effective therapeutics for urgent health needs, we encourage you to apply. We look forward to hearing from you!