Senior Systems Engineer, GXP Systems

The Role

Joining Moderna means advancing mRNA science to transform medicine. This role sits at the intersection of digital, automation, and quality, driving the design and evolution of advanced laboratory instrumentation ecosystems for Moderna’s new Harwell facility.

What You’ll Do

• Design, deploy, and manage a growing portfolio of benchtop instrumentation and enterprise laboratory systems supporting QC laboratories.
• 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 QuantStudio/3730, RAMAN TruScan, Chromeleon CDS, LogiLab SDMS and CFR Gateway, SoftMax 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.

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 biopharmaceutical GMP environment.
• Direct experience with automation solutions such as Hamilton Venus preferred.
• Experience with GAMP and GxP compliance regulations.
• Experience in laboratory systems, including data integrity regulations, instrument integration and laboratory digital workflow optimization.
• Experience working with Digital systems hosted in cloud and understanding of connectivity between on‑prem systems and SaaS/Cloud.

What You’ll Bring to the Table (Preferred Qualifications)

• Creative/innovative/problem solver that actively drives progress.
• Ability to work independently and make sound and timely decisions to achieve expected results.
• Strong understanding of core laboratory systems, related processes, and quality management workflows.
• Strong interpersonal skills with the ability to build successful professional working relationships.
• Ability to participate on multiple concurrent projects in a fast‑paced environment.
• Ability to effectively collaborate in a dynamic, cross‑functional matrix environment.
• A desire to make an impact as part of a high‑growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Pay & Benefits

• Best‑in‑class healthcare, plus voluntary benefit programs to support your unique needs.
• A holistic approach to well‑being with access to fitness, mindfulness, and mental health support.
• Family building benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
• Savings and investments to help you plan for the future.
• Location‑specific perks and extras.

Equal Opportunity & Reasonable Accommodation Statement

Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Applicants requiring accommodation may contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.

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