Laboratory Systems Validation Specialist I

Labcorp • Indianapolis, IN

1d

About The Position

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.

Requirements

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

Nice To Haves

• 1 or more years experience of knowledge of lab workflow and processes
• 1 or more years experience in software testing or audits
• Knowledge of SDLC/GAMP is a plus.

Responsibilities

• 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.
• Gather and document system requirements using established methodologies.
• Create and maintain validation documentation; experience in GxP and CAP/CLIA environments preferred.
• 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.
• 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.
• 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.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level