6 months ago
The Device Engineering group at GSK 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.
We are looking to recruit a talented Device Development Technologist you will be a graduate in Mechanical Engineering, Biomedical Engineering or related degree. You will 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.
You must be able to demonstrate your ability to manage projects and small internal and external teams. Additionally you need to be able to demonstrate 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.
You will be required to work with the design team to;
• Manage the interface between the design team and the Project Team
• Manage the development and population of the Design History File in support of any new programme
• Responsible for the compilation of all regulatory files
• 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.
Please ensure you apply before 8th AUG 2019 to ensure you’re in the running!
(Please take a personal copy of the Job Description, as this will not be available online post closure)
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact. This will help us to understand any modifications we may need to make to support you throughout our selection process.
• 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
GSK is a science-led, global healthcare company that produces innovative medicines, vaccines and consumer healthcare products.
We are committed to overcoming some of the biggest challenges in global health; delivering products of value in a responsible, sustainable way; and providing access to medicine for the world's poorest communities
You may apply for this position online by selecting the Apply now button.
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