Principal Device Engineer - Analytical & Operations

We are looking for an enthusiastic and experienced individual to lead and champion analytical quality, compliance and safety within Device Engineering (DE) in support of the development of new drug device combination products. Do you enjoy a challenging role with the opportunity to deliver robust products that improve the patient experience and can give them access to life changing medicines from the comfort of their own home? The role of Principal Device Engineer - Analytical & Operations within Device Engineering Analytical is part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices. The role is to be based at GSK's R&D site in Ware, Hertfordshire (UK). In this role you will….

• Be responsible for developing and maintaining the Learning and Development infrastructure which includes competency frameworks and training plans required to support business needs.
• Be expected to train as a business lead investigator (BLI), manage/lead analytical quality event e.g. deviations, CAPA's, customer complaints, change control and critically evaluate new processes with respect to quality and compliance requirements.
• Effectively communicate with managers, team members and Quality Leads on the performance of the team in relation to quality and compliance issues and standard ways of work using data and metrics to support this.
• Work closely with and become a conduit into quality groups e.g. validation, compliance, risk, Knowledge Management & Training, etc. Represent the department at applicable forums to ensure best practice is applied and harmonized
• Support the leadership team with the co-ordination of inspection readiness activities for both internal and external inspections and front audits for all QMS activities alongside the Analytical & Operations Manager (e.g. IBM, MHRA, etc)
• Review laboratory quality documents and experiments, ensuring compliance to all relevant quality WoWs e.g. eLNB, LIRs, deviations, testing methods, validation documentation, trending reports, etc
• Be expected to support the testing team to occasionally perform various types of analysis of devices in the laboratory (full training will be provided)., 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.
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We are looking for professionals with these required skills to achieve our goals:
• A graduate in the field of Science or Engineering
• Direct experience of leading quality compliance in an analytical environment
• Demonstrated application of the principles of GMP
• Knowledge of analytical processes and procedures
• Experience of managing quality events (e.g. LIRs, CAPA, deviations, RCA, change control, etc)
Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus:
• Experience of analytical processes and procedures
• Significant experience ensuring quality and compliance in a laboratory environment
• Experience in developing strategies to ensure quality compliance and creating & embedding those new ways-of-working successfully
• Knowledge/experience of validation activities within a laboratory environment (i.e. equipment and method)
• Knowledge/experience in the management of laboratory safety systems (e.g. Risk Assessments, WERA, etc)
• Experience of supporting internal and external audits
  
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Find out more: Our approach to R&D. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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