Senior Medical Device Engineer
Max Rate £41.20p/h PAYE - £53.36p/h via Umbrella
‘Be You’ at GSK
At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.
We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.
As a modern employer, we empower you to be yourself, share ideas and work collaboratively
Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organisation accountable for delivering robust, cost effective and competitive products, and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialisation. These activities are delivered through state of the art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.
Within Biopharm Process Development sits GSK’s Device Engineering team; an in-house device development group charged with the delivery of robust, patient-centric devices that enable the effective delivery of novel pharmaceuticals. Device Engineering is a multi-skilled team of Engineers and Scientists who work across all stages of the product and process development lifecycle, from concept design and selection through to the regulatory submission and commercial supply.
In this role you will
· Use problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges.
· Support device development work streams for R&D combination product development projects.
· Work across platform devices, co-ordinating development activities and managing platform documentation.
· Collaborate with multi-disciplinary teams across GSK and international sub-contractors.
· Facilitate risk assessments (e.g. user, design or process risk assessments)
· Participate in design reviews at critical stages of device development.
· Participate in device development project team meetings, ensuring development deliverables are met.
· Compile device development documentation including Design History Files and Risk Management Files.
· Co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance.
· Work closely with the manufacturing organisation to ensure that methods and processes are transferred successfully for commercial production.
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
· 1st or 2:1 in Mechanical Engineering, Biomedical Engineering or related degree.
· Experience of medical device or combination product development.
· 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.
· Ability to quickly establish relationships with internal and external stakeholders.
· Strong communication skills.
· Thrives in fast paced environments.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
· Experience in the regulatory pathways for combination products.
· Experience with global submissions, agency interactions and authoring dossiers.
· Excellent written and verbal communication skills
· Strong time management/organisational skills
· Evidence of team working skills and flexibility