Life Sciences Pharmaceuticals
CY Partners have an exciting opportunity for a Device Technologist to join a leading global pharmaceutical company based in Hertfordshire.
As a Device Technologist you will be part of the Device Engineering group. This group is an in-house design and development group charged with the development of drug delivery platforms to support the effective delivery of novel pharmaceuticals. The group comprises a multi-disciplinary group of skills – Industrial Design, Computer Aided Engineering, Computer Aided Design, Mechanical Engineering, Assembly Design, Packaging Design etc. – who develop novel concepts to establish clinical manufacturing/assembly capability with the objective of establishing a design suitable for high volume commercial supply.
You should have experience of the development, manufacture, testing, and quality control of medical devices/combination products. Experience in the regulatory pathways for combination products is essential.
As a device technologist you should be able to demonstrate your ability to manage projects and small internal and external teams. Additionally you will have the opportunity to demonstrate your problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges. You must demonstrate your ability to effectively communicate the development programmes to the wider development team and stakeholders.
Some responsibilities of the role include:
• Managing the interface between the design team and the Project Team
• Managing the development and population of the Design History File in support of any new programme
• Be responsible for the compilation of all regulatory files
• Be responsible for management of governance reviews boards in support of the project team
• Accountable for the execution of patient handling studies, design verification, design validation and QbD protocols for each project
• Establishment of manufacturing and quality control systems at external suppliers.
Experience in the following areas would be an advantage:
• Proven track record in product and process development and validation
• Experience with global submissions, agency interactions and authoring dossiers
• Comprehensive understanding of design controls, including 21CFR 820.30, risk management processes (ISO 14971), QMS (ISO 13485), relevant human factors and usability guidance, EU MDR, etc
• Excellent written and verbal communication skills
• Excellent negotiation skills
• Management of external manufacturing supply bases
• An understanding of the principles of design for manufacture
• Evidence of problem solving
• Understanding of plastics injection moulding or other high volume
• Strong time management/organisational skills
• Performance driven, driving for results and success with a sense of urgency
• Evidence of team working skills and flexibility
If you are interested in applying for this role or want further information, then please contact Helen at CY Partners on 0191 477 4733 or email your CV across to [email protected]