Principal Device Engineer

GSK; Tonwell; Hybrid; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Hybrid working

Job summary

GSK is seeking a Principal Device Engineer to join the Device Development and Engineering team at GSK's R&D site in Ware, Hertfordshire (UK). The role offers flexible hybrid working and occasional travel.

You will lead device development, collaborate with global teams, manage design controls, and contribute to regulatory submissions. The position requires a degree in Mechanical or Biomedical Engineering and strong experience in drug delivery devices.

Qualifications

• A degree or equivalent in Mechanical Engineering, Biomedical Engineering or related discipline.
• Significant experience in drug delivery devices and combination products development.

Responsibilities

• Provide technical leadership during development and industrialisation of drug delivery and combination product programmes.
• Collaborate with multi-disciplinary teams across the GSK network and external partners.
• Work within the design control framework to develop and execute work packages for platform-based DDF and RMFs.
• Contribute to authoring device parts of global submissions (technical file, BLA/MAA) and agency interactions.

Job description

The Principal Device Engineer role sits in GSK's Device Development and Engineering team is a high-performing group of scientists and engineers charged with the development and industrialisation of GSK's drug delivery devices and combination products. We operate across all modalities and are looking for an experienced Device Engineer to combine core engineering expertise with strong technical, project and matrix leadership to deliver robust, reliable and patient centric device platforms that enable GSK's late-stage portfolio. The role is to be based at GSK's R&D site in Ware R&D, Hertfordshire (UK) and can offer flexible hybrid working. Occasional travel may also be required. In this role you will…

• Provide technical leadership during the development and industrialisation phase of drug delivery and combination product programmes
• Collaborate with multi-disciplinary teams across the GSK network and external device development and supply partners
• Work within the design control framework to develop and execute work packages that form the basis of platform based DDF and RMFs
• Contribute to the authoring of device parts of global submissions (e.g. technical file, BLA / MAA) and agency interactions.
  A degree or equivalent in Mechanical Engineering, Biomedical Engineering or any related discipline
• Significant experience in drug delivery devices and the development of combination products (covering respiratory and/or parenteral dosage forms)
• Experience with requirements management, design controls, risk management, verification, validation and testing (ISO 14971 and 13485)
• A good understanding of assembly, scale up and tech transfer to manufacturing
• A good understanding of usability and human factors
• Strong leadership, teamwork and project delivery skills
• Clear written and verbal communication, CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer
  At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together., Uniting science, technology and talent to get ahead of disease together.
• At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology and talent to get ahead of disease together., Uniting science, technology and talent to get ahead of disease together.
• GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the Link where you will find answers to multiple questions we receive