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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Systems Administrator, Electronic GxP Systems - **Company:** KALEO INC - **Location:** Richmond, VA, United States (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Microsoft Windows, Information Systems, Data Integrity, Document Management Systems, Documentum, Network Troubleshooting, Metadata, System Testing, Test Execution Engine, Iq/oq/pq, Information Technology, Trackwise, Tools for Reporting, Veeva, GXP - **Published:** June 19, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=12ab72745dbcfbbb ## About the Role Do you have experience in Test validation method?, * Strong working knowledge of applicable regulations and standards related to electronic GxP systems, including 21 CFR Parts 11, 210, 211, 820/QMSR, ISO 13485 and applicable ICH guidance * Demonstrated expertise in data integrity principles (ALCOA+) and their application with electronic systems * Ability to assess GxP impact and apply appropriate controls for GxP-supporting systems * High technical judgement in executing system changes while maintaining compliance and inspection readiness * Excellent analytical and problem-solving skills, with the ability to troubleshoot system issues and implement effective, compliant solutions * Strong written and verbal communication skills, particularly when explaining system functionality and compliance concepts to non-technical users * Ability to manage multiple system activities and priorities independently while maintaining accuracy, traceability, and quality * Detail-oriented, execution-focused mindset with a demonstrated record of reliable follow-through * Comfortable operating as an individual contributor in a regulated environment with clear accountability for system execution. To be considered for the position, you must have: * Bachelor's or Master's degree in a scientific, technical, or information systems-related discipline (e.g., life sciences, engineering, computer science, or equivalent experience) * Minimum 6+ years of experience supporting Quality Assurance systems in a regulated pharmaceutical, biotechnology, medical device, or combination product environment * Demonstrated hands-on experience administering electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or equivalent quality systems * Proven experience supporting validated system lifecycles, including system implementation, configuration, change control, upgrades, and decommissioning * Working knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated state * Strong proficiency with Microsoft 365 and system reporting tools * Experience supporting internal audits and regulatory inspections as a system SME * Ability to travel occasionally (up to ~10%) as required for system support or inspections ## Description Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind. The Systems Administrator, Electronic GxP Systems is a critical contributor to a high-performing Quality Assurance organization focused on building reliable, inspection-ready systems that support compliant execution at-scale. This role ensures that electronic GxP and GxP-supporting systems remain validated, traceable, and defensible, forming a stable digital foundation for quality oversight and decision-making. The position serves as the hands-on technical authority for electronic quality systems, including MasterControl and other systems & applications, and ensures these systems remain in a state of control throughout their lifecycle. The ideal candidate is a hands-on technical expert with deep experience in validated systems, data integrity, and electronic quality tools, who thrives in execution and takes ownership of keeping systems in a continuous state of control. Operating in a regulated pharmaceutical and combination-product environment, this role enables teams to focus on risk, performance, and improvement - confident that the systems underpinning the work are sound. As Systems Administrator, Electronic GxP Systems you will: * Serve as the system administrator and execution owner for all electronic GxP systems and GxP supporting applications used to create, manage, store, or report regulated quality data * Maintain a complete and current inventory or electronic GxP and GxP-supporting systems, including system purpose, GxP impact, validation status, and system ownership * Ensure all applicable systems are appropriately classified for GxP impact, validated and maintained in a validated state, traceable to intended use and regulatory requirements, and defensible during audits and inspections * Serve as the primary or backup system administrator for multiple electronic systems platforms, for example: platforms and systems supporting document control, training, change control, deviations, investigations, CAPA, audit, customer complaint workflows, electronic batch records, external submissions, and device history file(s) * Configure, maintain, and execute system workflows and forms, metadata and taxonomy structures, user roles, permissions, and security models * Controlled system changes in accordance with validation requirements * Provide quality system execution oversight for GxP-supporting applications that interface with or support GxP activities (e.g. reporting tools, repositories, workflow platforms, and validated interfaces) * Partner with Information Technology and systems owners to ensure appropriate approach and documentation, controlled access and data protection(s), and change management aligned with GxP risk profile * Execute and support system validation activities across the system lifecycle, including validation planning and impact assessments, IQ/OQ/PQ documentation and test execution, and validated evidence maintenance and archival * Ensure all system changes, upgrades, and enhancements follow approved change control and validation procedures * Maintain inspection-ready validation documentation at all times. * Develop, maintain, and execute system-level reports while ensuring system data is accurate, reliable, attributable, legible, contemporaneous, original, and complete (ALCOA+) * Serve as a system subject matter expert (SME), including back-room inspection support and direct system demonstrations as required * Provide day-to-day technical support for electronic GxP systems, including issue triage, troubleshooting, and resolution while evaluating new system features and tools to provide recommendations based on compliance and operational impact * Participate in industry forums, user groups, and training related to electronic GxP systems and validation best practices ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [A Data Mesh needs Open Metadata](https://www.wearedevelopers.com/videos/505-a-data-mesh-needs-open-metadata) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [Crafting Custom Frameworks with Rust: A Deep Dive into Procedural Macros](https://www.wearedevelopers.com/videos/849-crafting-custom-frameworks-with-rust-a-deep-dive-into-procedural-macros) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Bringing Clarity to Event Streams: Enabling Analytics and AI Through Rich Metadata](https://www.wearedevelopers.com/videos/1616-bringing-clarity-to-event-streams-enabling-analytics-and-ai-through-rich-metadata) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Best Companies to work for in London: Top 25 Companies in 2023](https://www.wearedevelopers.com/magazine/187-best-companies-to-work-for-in-london-top-25-companies-in-2023) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Find a Developer Job: 12 Best Job Sites For Developers](https://www.wearedevelopers.com/magazine/165-find-a-developer-job-12-best-job-sites-for-developers) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)