GxP GMP Lab IT Support Specialist

TechDigital Group; Frisco (TX); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking Lab Support Specialists to ensure the efficient operation of internal desktop lab systems. This role involves providing direct support to end-users, managing service requests, and collaborating with QA/QE teams to evaluate system upgrades. The ideal candidate will have a strong understanding of GxP operations and experience in desktop support within a GMP environment. Join a dynamic team dedicated to maintaining compliance and enhancing operational efficiency in a regulated setting. This is a fantastic opportunity to contribute to impactful projects and work alongside talented professionals in the field.

Qualifications

• In-depth knowledge of GxP operations related to FDA's CFR 21 Part 11.
• Experience in desktop support in a GMP environment.

Responsibilities

• Provide workstation support and resolve Tier 1 - 2 issues.
• Administer updates on QC/Manufacturing instruments/systems.

Skills

GxP experience

Desktop Support

Windows Desktop OS support

Good Documentation Practices (GDP)

Service request management

Tools

Sparc ticketing system

QC Lab/Manufacturing systems

Job description

Mandatory skills:
1. Strong hands-on experience with microservices architecture (Spring Boot, REST APIs, API Gateway). 2. Working knowledge of HealthCare, Clinical & Care Management - Preferred 3. Familiarity with ITIL processes (Incident, Problem, Change Management, Production Checkout Support, BreakFix / Hot Fix)

Key Responsibilities
· Lead L2/L3 production support for microservices applications, ensuring adherence to SLAs/OLAs. · Act as primary technical escalation point for critical incidents; drive triage, diagnosis, and resolution. · Perform root cause analysis (RCA) for major incidents and drive permanent fixes/preventive actions. · Monitor application health, logs, and performance metrics using Splunk, Grafana, AppDynamics, Prometheus. · Manage deployment, configuration, and troubleshooting of microservices on Kubernetes/OpenShift/container platforms. · Coordinate with development, DevOps, infrastructure, and database teams for issue resolution and change management. · Review and approve incident, problem, and change tickets (ITIL process) in tools like ServiceNow/JIRA. · Guide and mentor a team of support engineers; assign tasks, review work, and ensure quality of resolutions. · Drive automation initiatives using Python/PowerShell scripting and AI tools (Copilot/Claude/GPT) to reduce manual effort — self-healing scripts, alert automation, runbook automation, code review assistance. · Ensure documentation of knowledge base articles, runbooks, and support playbooks is current. · Participate in on-call rotation and manage major incident bridge calls when required. · Provide regular status reports, dashboards, and metrics to stakeholders (MTTR, ticket volume, aging, trends). · Support release management activities including deployment validation, smoke testing, and rollback planning.

Required Technical Skills
· Strong hands-on experience with microservices architecture (Spring Boot, REST APIs, API Gateway). · Working knowledge of HealthCare, Clinical & Care Management - Preferred · Familiarity with ITIL processes (Incident, Problem, Change Management, Production Checkout Support, BreakFix / Hot Fix). · Experience with containerization & orchestration: Docker, Kubernetes/OpenShift. · Cloud exposure: Azure (Preferred) / GCP. · CI/CD tools: Jenkins, Git EMU / Git Actions, Azure DevOps. · Database: MySQL, SQL Server, PostgreSQL, MongoDB. · Programming Language: Java, Spring Boot Microservices, REST APIs. · AI Tools / LLMs: GitHub Copilot, Microsoft Copilot, Claude, GPT, Gemini, OpenAI — for code assistance, automation, and productivity gains in support workflows. · Monitoring/Observability Tools: Splunk, Grafana, AppDynamics, Prometheus. · Middleware/Messaging: Kafka.
· Scripting: Python, PowerShell, or similar for automation.

Soft Skills
· Strong analytical and problem-solving skills under time pressure. · Excellent verbal and written communication for stakeholder and client interaction. · Leadership and mentoring capability. · Ability to work in rotational shifts/on-call support model.