Lead Engineer, Evidence Management

About the role

Johnson & Johnson is looking for a Lead Engineer, Evidence Management to join its Scientific Affairs and Regulatory Affairs team in Limerick, Ireland (also posted for Raritan, NJ). The role leads engineering, application architecture and delivery governance for the evidence management digital ecosystem, which is primarily Appian-first, AI-enabled and ecosystem-oriented. It is mainly focused on Regulatory Affairs, with Scientific Affairs as an adjacent stakeholder group. The role is primarily hybrid for candidates within commuting distance of a US office (preferably New Jersey); remote candidates may be considered on a limited basis.

Key responsibilities

• Own the application architecture strategy and engineering roadmap for evidence management across Regulatory Affairs and Scientific Affairs, and define Appian design standards.
• Design scalable, compliant solutions for regulatory platforms, Appian applications, data flows, workflows, integrations, content repositories and analytics, and drive design governance.
• Ensure solutions meet enterprise standards for cloud, cybersecurity, privacy, lifecycle management and technical sustainability.
• Extend evidence management patterns to Scientific Affairs use cases such as evidence intake, evaluation, collaboration workflows and knowledge search.
• Define the AI-enabled roadmap (Generative AI, machine learning, NLP, semantic search, knowledge graphs, agentic workflows) and guide pilots with security, usability and compliance controls.
• Define data architecture principles and engineering standards for APIs, event-driven integration, data lineage, data quality and platform interoperability.
• Ensure engineering decisions support GxP, SOX, privacy, cybersecurity, auditability, data integrity and validated SDLC practices, working with Quality, Security, Privacy, Regulatory Affairs, Scientific Affairs and Data Governance.

Required profile

• Bachelor's degree in Computer Science, Engineering, Information Systems, Data Science, AI/ML or a related field.
• 10+ years of progressive experience in software engineering, application architecture, solution architecture, platform architecture, low-code platform architecture, data architecture or enterprise technology delivery.
• Mandatory hands-on experience engineering, architecting and delivering on the Appian platform, including solution design, integrations, data models, rules, role-based security and environment management.
• Strong experience leading Agile or SAFe delivery, and experience with AI-enabled enterprise solutions (Generative AI and/or machine learning).
• Experience supporting regulated business functions such as Regulatory Affairs, Scientific Affairs, Quality, Clinical, Safety, R&D or Life Sciences.
• Working knowledge of GxP, SOX, privacy, cybersecurity, data integrity, regulated SDLC, validation, qualification or computerized system assurance.

Required skills

• Appian platform architecture and solution design (mandatory)
• Agile or SAFe delivery
• Large language models, prompt engineering, semantic search, vector databases, retrieval-augmented generation, model orchestration and responsible AI controls
• Cloud-native, API-enabled, workflow-enabled platforms
• Preferred: Appian certification, Azure AI services, TOGAF, SAFe Architect/Agilist, experience with Regulatory Affairs or Scientific Affairs platforms

What we offer

• Base pay range of EUR 71,200 to EUR 123,165
• Annual bonus, vacation days, parental leave of at least 12 weeks, bereavement, caregiver and volunteer leave, well-being reimbursement and health programmes
• Service anniversary and recognition awards, and insurance plans for eligible employees and dependents