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 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 offer a functional service provider solution, allowing our customers to leverage our staff's expertise while providing employees with the opportunity to work onsite at a pharmaceutical/biopharmaceutical company, maintaining full-time 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 in accordance with Non-GMP and GMP requirements.
Support verification of medical device analytical methods, including validation, transfer, and equivalence.
Develop medical device analytical methods.
Conduct investigations on medical devices, including disassembly, visual inspection, and X-Ray or CT scanning.
Lead and contribute to internal self-inspection audits, respond to audit findings, communicate results, 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 other manufacturing equipment, ensuring proper registration and maintenance.
Plan laboratory activities to ensure timely project delivery.
Review and approve experimental documentation.
Education and Experience:
B.S./M.S. in Engineering, Analytical Science, Chemistry, Life Science, or related field, with 1-3 years of laboratory experience in the pharmaceutical industry.
Knowledge, Skills, and Abilities:
Understanding of GMP and non-GMP analysis and data integrity within a GxP environment.
Experience with analytical method validation and transfer.
Proven ability to deliver projects within complex, multidisciplinary teams across organizational and cultural boundaries.
Strong project management and multitasking skills.
Excellent communication skills and self-motivation.
Knowledge of medical device testing and ISO standards is highly desirable.
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 invite you to apply. We look forward to hearing from you!
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