At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
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.
Thermo Fisher Scientific are currently hiring for a Sr Scientist to provide support for multiple device development work streams for R&D combination product development projects. The role will be based at our client’s site in Ware, Hertfordshire, UK and can offer hybrid working. As a Senior Scientist you will be tasked with:
* Support packaging and device development work streams for R&D integral drug device combination and/or co-packaged product development projects.
* Management of Design History File (DHF) documentation
* Ownership of device work packages, co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure combination product safety and performance
* Author device development documentation including Design History Files (DHF) and Risk Management Files (RMF).
* Participate in packaging and device risk assessments (e.g. user, design or process risk assessments) as needed
* Participate in design reviews at critical stages of development as needed
* Supplementary activities to support specific projects as required
Essential Qualifications/Experience:
* Graduate in Mechanical Engineering, Biomedical Engineering or related degree
* Experience of medical device or combination product development.
* Understanding and experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP.
* Experience in Design History File, Risk Management File, and design controls for combination product experience in the pharmaceutical industry
Preferred Qualifications/Experience:
* Experience in sterile drug primary packaging development for large and small molecules including vial/stopper, pre-filled syringes, and cartridges presentations.
* Knowledge of device and packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc, ISO).
* Knowledge of integral and non-integral parenteral packaging materials (such as vials, stoppers, PFS, syringes, needles), components, vendors, analytical equipment, and technologies.
* Knowledge of domestic and international device and packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc, ISO).
* Knowledge of statistical analysis and Design of Experiments
* Ability to quickly establish relationships with internal and external stakeholders.
* Strong time management / organizational skills.
* Evidence of team working skills and flexibility.
Benefits
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status
#J-18808-Ljbffr