Senior Systems Engineer, GXP Systems

*
* The Role:

** Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is establishing a leading research, development, and manufacturing facility at Harwell to support onshore mRNA vaccine production for respiratory diseases in the UK.This long term investment will create skilled jobs and strengthen collaboration with academic, NHS, and government partners. We welcome experts ready to help expand access to life saving vaccines.

This role sits at the intersection of digital, automation, and quality, driving the design and evolution of advanced laboratory instrumentation ecosystems.

You will shape how benchtop and enterprise systems connect into a unified, intelligent digital lab environment.

Working within the Digital Quality team, you will combine hands-on engineering expertise with strategic thinking to enable scalable, compliant, and future-ready laboratory operations.
** Here’s

What You’ll Do:

*** Design, deploy, and manage a growing portfolio of benchtop instrumentation and enterprise laboratory systems supporting Quality Control laboratories, ensuring seamless integration with connected digital platforms.
* Own the full product lifecycle management of instrumentation software and systems, including validation, optimization, integration, support, maintenance, and version upgrades across platforms such as Thermo Omnic FTIR, HIAC Particle Counter, TOC, Thermo Quant Studio/3730, RAMAN Tru Scan, Chromeleon CDS, Logi Lab SDMS and CFR Gateway, Soft Max Pro, MODA, and Labvantage LIMS/LES.
* Collaborate closely with internal and external business analysts, automation and software engineers, and the TCoE to deliver robust and scalable digital lab solutions.
* Translate complex system, equipment, and data integration requirements from Digital and Business teams into effective and compliant digital lab system implementations.
* Lead and support change control and regulatory documentation, including living documents, SOPs, work instructions, and knowledge base materials to ensure inspection readiness and compliance.
* Partner with digital stakeholders to validate and integrate systems into connected instrument pipelines, enabling future robotics, automation, and AI-driven capabilities across the laboratory landscape.
* Actively foster innovation by challenging existing processes and leveraging emerging technologies, including opportunities to integrate Generative AI and advanced digital solutions into laboratory workflows.
* Apply an operational excellence mindset to identify, design, and implement process improvements that enhance system performance, user experience, and business efficiency.
* Ensure GMP compliance is embedded in the design, delivery, and lifecycle management of all systems.
* Maintain a constant state of inspection readiness through strict adherence to internal quality policies, procedures, and training requirements.
* Serve as a digital quality subject matter expert during internal and external audits for the assigned system portfolio.
* Operate as a hands-on individual contributor within a fast-paced environment, defining new processes where none exist and collaborating effectively with expert peers.
* Maintain an on-site presence in Harwell, with potential travel between regional sites as required.
* Take on additional responsibilities as needed to support evolving business and technical priorities.
** The key Moderna Mindsets you’ll need to succeed in the role:
*** We digitize everywhere possible using the power of code to maximize our impact on patients.
* We act with dynamic range, driving strategy and execution at the same time at every step.
** Here’s What You’ll Need (Minimum Qualifications)
*** Bachelor’s degree or equivalent in science, engineering or computer science
* 5 to 7+ years’ experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a in biopharmaceutical GMP environment
* Direct experience with automation solutions such as Hamilton Venus preferred
* Experience with GAMP and GxP compliance…