Lead Validation Engineer
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Lead validation engineer ensuring GxP compliance for Dotmatics’ Luma scientific software platform. Authoring validation documentation, coordinating testing, and supporting audit readiness.
Responsibilities:
- Lead validation activities for the Dotmatics Luma platform and internal systems operating under GxP requirements
- Serve as the subject matter expert for computer system validation (CSV)
- Ensure software development, testing, and release activities comply with applicable regulations and standards
- Author, review, and approve validation lifecycle documentation, including Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ, OQ, and PQ protocols and reports
- Work with software quality and DevOps teams to leverage automated tools such as Cypress for IQ, OQ, and PQ protocols
- Apply GAMP 5 to determine validation strategies and documentation requirements
- Mentor and lead junior validation team members and QA staff
- Provide validation guidance and training to engineers, QA analysts, and project managers
- Support customer-facing validation activities
- Coordinate validation testing and defect resolution
- Assist with CAPA investigations and audit responses
- Collaborate with Quality Management on document control, periodic reviews, and audit readiness
Requirements:
- Deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements as they apply to software systems
- Familiarity with ISO 9001 quality management system principles
- Demonstrated experience authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports
- Experience using automated testing tools such as Cypress or Playwright to generate and capture test evidence
- Understanding of software development lifecycle (SDLC) and Agile methodologies
- Experience validating cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software
- Bachelor’s degree in Computer Science, Biology, Chemistry, Engineering, or a related field (preferred but not required)
- Background in regulated life sciences environments, such as pharmaceutical, biotech, or medical device industries
Benefits:
- Dynamic, remote-friendly environment
- Collaborative global team
- Equal opportunity workplace
- Supportive and connected work environment
Similar Jobs
Traveling Project Engineer – Special Projects Division
Traveling Project Engineer supporting NexGen Contracting’s construction projects. Assisting with scheduling, cost reporting, procurement, safety, production tracking, and change orders.
Lead Validation Engineer
Lead validation engineer ensuring GxP compliance for Dotmatics’ Luma scientific research software platform. Driving CSV documentation, automated testing, audit readiness, and regulatory validation activities.
Senior Nuclear Engineer
Senior Nuclear Engineer supporting EPU and MUR projects for commercial nuclear power generation. Evaluating plant modifications, systems, calculations, and regulatory requirements.
Senior Algorithm Engineer – Autonomous Vehicles
Senior Algorithm Engineer developing perception-and-map-fused 3D world models for NVIDIA autonomous vehicles. Leading real-time navigation algorithms, HD mapless driving, and team mentoring.
Lead Tenable Engineer
Lead Tenable Engineer modernizing CACI’s Air Force ACAS cybersecurity architecture. Building Tenable, Red Hat Linux, Azure, and Kubernetes solutions for mission systems.
Agent Engineer
LLM agent engineer discussing production reliability, evaluation, and adoption with Mercor. Completing conversational and live interviews based on real agent-operating experience.
Propulsion & Effects Engineer
Propulsion and effects engineer creating dual-use safety prompts and evaluating frontier AI responses. Applying real hardware and test-data expertise to distinguish legitimate requests from dangerous misuse.
Structured Data Foundation Model Engineer, Modern Data Stack
Structured Data Foundation Model Engineer developing unified AI models for databases, graphs, tabular data, and time series at NVIDIA. Advancing architectures, benchmarks, training, and inference for real-world applications.
Agent Engineer
Agent Engineer assessing production LLM reliability, evaluation, observability, and adoption. Contract research conversation for Mercor, an AI hiring platform.
Emulation Engineer
Emulation Engineer building and debugging RTL-based models for Intel SoC and IP validation. Developing emulation environments, automation, and verification tools.
Senior Virtualization Engineer
OpenShift virtualization engineer managing VMware, Kubernetes, and OpenShift platforms for SS&C’s financial-services and healthcare technology customers. Automating migrations, cluster operations, and application delivery.
Agent Engineer
Agent Engineer assessing production LLM agent reliability, evaluation, observability, and adoption. Mercor pays for expert interviews on real-world agent systems.
Senior Thermal Analysis Engineer
Senior Thermal Analysis Engineer analyzing thermal performance and designing cooling solutions for SolarEdge’s solar, storage, and EV energy products. Collaborating with electrical and mechanical designers on validated, cost-optimized designs.
Tech Services Engineer – Midstream and Downstream
Remote technical field engineer supporting Univar Solutions customers in midstream and downstream oil and gas. Troubleshooting operations, optimizing applications, and driving technical sales growth.
Journeyman Marine Propulsion Engineer
Marine propulsion engineer supporting U.S. Coast Guard vessel modernization and lifecycle engineering. Analyzing propulsion systems, ship machinery, and technical designs.
Principal Forward Deployed Engineer
Principal Forward Deployed Engineer embedding with customers to build secure agentic AI solutions. Integrating Docker with enterprise identity, Kubernetes, registries, and CI/CD systems.
Intermediate XR 3D Engineer
Intermediate XR 3D Engineer building Unity and C# AR features for Eterio’s FabStation industrial fabrication software. Developing HoloLens 2 and tablet experiences for steel fabricators.
Application Packaging Engineer
Application Packaging Engineer building and troubleshooting Windows application packages for the Department of Veterans Affairs. Supporting reliable enterprise deployment across thousands of federal endpoints.
Lead EHV Transmission Line Engineer 2 – Grid
Lead EHV transmission engineer designing 69kV–765kV power lines for Sargent & Lundy. Reviewing PLS-CADD models, guiding teams, and coordinating client-compliant engineering designs.
Engineer II, Field Service
Field Service Engineer II installing, troubleshooting, and repairing analytical instruments for Thermo Fisher Scientific. Supporting research, industrial, and healthcare customers across Iowa’s assigned territory.