> Markdown version of [/jobs/ext/1104551-msat-device-engineer](https://www.wearedevelopers.com/jobs/ext/1104551-msat-device-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # MSAT Device Engineer - **Company:** Gsk's Zebulon - **Location:** United States (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Computer-Aided Design, Adobe InDesign, Data Analysis, Iq/oq/pq, Hardware Testing - **Published:** June 9, 2026 - **Apply:** https://www.dice.com/job-detail/84745d1a-311f-40d8-9d1f-0db51c3a60a8 ## About the Role * Bachelor's Science degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering. * 5+ years' experience in pharmaceutical or biopharmaceutical manufacturing, process development, MSAT or technical operations, with a focus on sterile injectables, especially pre-filled syringe and auto injector formats. * Experienced with Product Lifecycle Management, including Control Strategies, Process Qualification, Change Control and Technical Risk Assessments. * Required experience working with raw materials, equipment, unit operations and testing for sterile injectables, especially pre-filled syringe and auto injector formats. * Commercial Medical Device Assembly experience Preferred Qualification If you have the following characteristics, it would be a plus: * Advanced degree in a relevant scientific or engineering field. * Proficient in use of technology to communicate and provide reports and analysis of data * Awareness of materials and major differences in the manufacturing methods of moulded components e.g. polymers, pigments and the various moulding techniques * Awareness/knowledge of Lean/Six Sigma tools * Competent knowledge of procurement systems and processes used to drive activities and deliver projects, with a detailed appreciation of compliance requirements * Awareness of existing supply base and of the industry in general as a source of new suppliers or specialist skills * Awareness/understanding of validation techniques and procedures * Knowledge of statistical procedures for data analysis * Knowledge of intellectual property considerations * Basic understanding of the pharmaceutical regulatory environment and the specific additional legislation needs for medical devices e.g. EC'CE' marking, FDA Medical Device guidance * Basic appreciation of pharmaceutical GMP, pre-approval inspection readiness and company regulatory requirements * Basic understanding to enable management of metrology and plastics testing techniques and procedures and GSK Specification and Drawing systems * Development of Medical Device Assembly process controls, including creation and/or maintenance of product control strategies * Device-Product knowledge * Injection Mould Tooling Design and Process * Polymer Science * Rubber Technology * Springs * Metal Forming * Device Testing * Device Assembly/Automation * Device Design CAD/CAE * Device Supply Base Management * Medical Device Regulations * RCA/DMAIC Problem Solving ## Description The Device Engineer provides technical expertise, guidance, oversight, and support for the associated device assembly, through effective Product Lifecycle Management (PLM) and support for day-to-day operations, to ensure the ongoing manufacture and supply of our products in alignment with Regulatory and Quality standards and business objectives. This role is a key addition to support the new specialty medicine assembly and pack hub at GSK Zebulon. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Act as technical lead for the device ensuring Critical Process Parameters are identified, understood, monitored and controlled. * Actively participate in the investigation team for device and equipment related issues. Lead quality investigations, RCA and CAPA associated with the device. * Responsible for delivering key technical activities including NPI trials and planned change implementation. * Lead/support development work in support of equipment installations and validation. * Maintain a strong level of validation understanding and proficiencies within life cycle management, including expertise in design controls, manufacturing technologies and upcoming combination products for commercialization. * Able to perform technical coaching of operators to ensure knowledge transfer to the manufacturing shop floor allowing operators to improve their accountability and timeliness of issue resolution. * Lead/support risk management activities through the life cycle for devices and conduct periodic risk reviews based on ISO requirements. Create/Maintain Device History Files. Provide technical SME input for complaints related to the device. * Drive the improvement of unit operation process capability and batch yields. Specifically, be accountable for Cost of Goods (CoGs) and Cost of Waste (CoW) improvements. ## Related Videos - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [The Innovation Formula: Fast Prototyping, Data Analysis, and Real User Insights](https://www.wearedevelopers.com/videos/1421-the-innovation-formula-fast-prototyping-data-analysis-and-real-user-insights) ## Related Articles - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [Software Engineer Salary London](https://www.wearedevelopers.com/magazine/252-software-engineer-salary-london) - [Why Upskilling And Reskilling is Important For Developers](https://www.wearedevelopers.com/magazine/428-why-upskilling-and-reskilling-is-important-for-developers) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023)