Scientist / Senior Scientist (Medical Device) - client dedicated
Scientist / Senior Scientist (Medical Device) - client dedicated
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Scientist / Sr Scientist (Medical Device) Ware UK
Thermo Fishers 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 fulltime benefits.
Summarized purpose:
This role will be supporting project delivery in the Device Engineering team in Drug Product Development Department within our clients site in Ware.
Essential Functions:
Perform medical device testing to NonGMP 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 XRay or CT scanning
Lead and input into the internal selfinspection 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 XRay equipment benchtop manufacturing equipment. Ensure laboratory equipment is registered and maintained to quality requirements
Plan practical activities within the lab to ensure successful ontime 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 13 years experience in an analytical laboratorybased role primarily within the pharmaceutical industry.
Knowledge Skills and Abilities:
Understanding of GMP and nonGMP analysisand 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 multidisciplinary 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
Selfmotivated 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 worlds most urgent health needs submit your application wed love to hear from you!
Required Experience:
Senior IC
Employment Type
Full-Time
