6516 - Laboratory Systems Specialist / Validation Engineer

Title: 6516 - Laboratory Systems Specialist / Validation Engineer Location: Indianapolis, IN

Validation Engineer Responsibilities:

• Support day-to-day operation of laboratory and quality systems, instrument workstations, and associated technologies, including configuration, troubleshooting, and maintenance of laboratory computers, software, peripherals, and connectivity
• Coordinate software installations, upgrades, patches, and controlled configuration changes, partnering with laboratory users and support teams to resolve incidents and minimize operational disruption
• Maintain accurate technical documentation and contribute to hardware and software lifecycle planning
• Support deployment of new laboratory instruments, applications, and computerized systems, including workstation builds, system configuration, and domain or network migrations
• Coordinate vendor installation, upgrade, and implementation activities, contributing to implementation planning, test preparation, cutover, deployment, and hypercare support, and document technical dependencies, issues, and risks for escalation
• Support computer system validation and computer software assurance activities throughout the system lifecycle, contributing technical input to impact assessments, risk assessments, change controls, validation plans, and test scripts
• Execute or support qualification and testing activities, collecting complete, attributable technical evidence, and support deviation investigation, discrepancy resolution, periodic review, and audit or inspection readiness within applicable GxP, data integrity, and security requirements
• Coordinate with infrastructure and cybersecurity teams on endpoint management, access, network, server, backup, and recovery dependencies, supporting vulnerability remediation, patching, and approved security controls for regulated systems
• Assist with backup, restoration, disaster recovery, and business continuity planning and testing, and escalate infrastructure or cybersecurity risks affecting system availability, compliance, or validated state
• Support assigned technical activities across projects, tracking actions and deliverables and providing status updates, while participating in cross-functional working sessions and identifying process improvement opportunities

Job Requirements:

• Bachelor's Degree in Information Technology, Engineering, Life Sciences, or a related field
• 3+ years of experience supporting laboratory, manufacturing, quality, or other regulated computerized systems
• Experience working in a GxP-regulated pharmaceutical, biotechnology, medical device, or comparable environment
• Hands-on experience with LIMS, Veeva, chromatography data systems, instrument software, or other laboratory informatics platforms
• Working knowledge of computer system validation, qualification, change control, and controlled documentation practices
• Strong technical troubleshooting, root-cause analysis, and written communication skills, with the ability to work independently and manage competing priorities
• Knowledge of GAMP 5, 21 CFR Part 11, data integrity principles, and risk-based validation or CSA methods
• Experience with Windows administration, Active Directory, endpoint management, server dependencies, networking, and backup or recovery solutions (Preferred)
• Experience supporting system migrations, hardware refreshes, vendor-led implementations, or cybersecurity remediation in regulated environments (Preferred)
• Experience authoring or reviewing validation and technical lifecycle documentation (Preferred)