Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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 have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Summarized purpose:
This role will be supporting project delivery in the Device Engineering team in Drug Product Development Department within our client’s site in Ware.
Essential Functions:
- Perform medical device testing to Non-GMP and GMP requirements
- Perform or support verification of medical device analytical methods i.e. analytical method validation, analytical method transfer, analytical method equivalence
- Perform medical device analytical method development
- Perform medical device investigations which may include disassembling medical devices, visual inspection and performing X-Ray or CT scanning
- Lead and input into the internal self-inspection audits and responses to audit findings. Communicate findings and good practices to the team and complete or assign required actions
- Assemble medical devices for analytical testing or stability purposes.
- Perform or support validation exercises for laboratory equipment e.g. force testing equipment, 3D printers, X-Ray equipment, bench-top manufacturing equipment. Ensure laboratory equipment is registered and maintained to quality requirements
- Plan practical activities within the lab to ensure successful, on-time delivery of projects.
- Review/Approve experimental write ups
Education and Experience:
- B.S./M.S. degree in Engineering, Analytical Science, Chemistry, Life Science, or equivalent industry experience, with minimum 1-3 years’ experience in an analytical, laboratory-based role, primarily within the pharmaceutical industry.
Knowledge, Skills and Abilities:
- Understanding of GMP and non-GMP analysis and their application in an analytical environment. Experience of working to industry expectations for data integrity within a GxP environment.
- Knowledge and experience of analytical method and equipment validation and transfer.
- Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
- Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects simultaneously
- Self-motivated and driven with strong communication skills.
- Knowledge of medical device testing and the ISO guidance requirements highly beneficial
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
