Laboratory Systems Validation Specialist I

Labcorp is seeking a Laboratory Systems Validation Specialist to join our team at Scicor Drive in Indianapolis, Indiana.

Work Schedule

Monday through Friday, day shift

Job Responsibilities

Technical & Operational Support

• Operate and support laboratory instruments, interfaces, LIS/LIMS, and middleware platforms (e.g., Data Innovations Instrument Manager, Siemens CentraLink).
• Lead and provide guidance during system validations for instruments, middleware, and other lab systems.
• Support change control processes for laboratory systems.
• Collaborate with SMEs to define expected system behaviors and translate them into clear technical requirements, including data workflow considerations across systems.
• Provide technical consultation to internal and external clients.

Leadership & Project Management

• Gather and document system requirements using established methodologies.
• Create and maintain validation documentation; experience in GxP and CAP/CLIA environments preferred. Knowledge of SDLC/GAMP is a plus.
• Lead testing activities for laboratory workflows, physical automation, and instrument middleware platforms.
• Oversee requirements gathering for middleware interface development.
• Coordinate with project managers and resource owners to support system testing.
• Ensure timely delivery of services and maintain strong client relationships.
• Drive client satisfaction and identify opportunities for additional business.

Performance Monitoring & Quality

• Monitor system testing progress and performance metrics; identify and escalate issues when needed.
• Review and prepare test results for QA to ensure complete, compliant test packages.
• Balance operational support duties with ongoing project responsibilities.
• Ensure adequate resource allocation to meet performance and quality standards.
• Maintain regulatory compliance.
• Collaborate with other sites and cross-functional teams.

General Responsibilities

• Perform qualification specialist duties as needed.
• Coordinate review, approval, and archiving of validation documentation.
• Provide written and verbal updates to project managers and leadership.
• Complete all HR- and training-related requirements; maintain an up-to-date training file.
• Submit monthly status reports.
• Support a culture of continuous improvement, quality, and productivity.

Minimum Qualifications

• 3 or more years' experience in a Laboratory System Analyst or Laboratory System Validations role.
• Bachelor of Science (BS) in Clinical Laboratory Science, Biology, Chemistry, Public Health, Microbiology, Computer, Technology, Animal Science, and/or Medical Technology

Preferred Qualifications

• 1 or more years experience of knowledge of lab workflow and processes
• 1 or more years experience in laboratory software testing such as Navify, FCS Express, Infinicyte
• 1 or more years of experience or supporting client audits by providing an overview of the system validation documentation 

Additional Job Standards

• Experience in IT/Computer validation (to leverage important inputs on how to handle the workflow, how to avoid data integrity problems, evaluate upfront solutions with less validation effort and capture any event possibility required by a system when setting complex rules)
• Experience in requirements gathering, documentation in a regulatory environment
• Strong knowledge of 21 CFR Part 11 requirements and CAP/CLIA regulations
• Background in information systems, data analysis, workflow analysis
• Ability to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory

About Labcorp

At Labcorp, we are a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions.

Through our unparalleled diagnostics and drug development laboratory capabilities, our nearly 70,000 employees combine cutting-edge innovation, science and technology to solve some of today’s biggest health challenges, accelerate life-changing healthcare breakthroughs and impact lives around the world.

Here, you are empowered to own your career journey and create a personalized development plan with the support of your team.

Benefits: Employees regularly scheduled to work 20 or more hours pe