Laboratory Systems Validation Specialist I

Labcorp•Indianapolis, IN

6d•Onsite

About The Position

Labcorp is seeking a Laboratory Systems Validation Specialist to join our team at Scicor Drive in Indianapolis, Indiana. This role provides technical and operational support for laboratory instruments, interfaces, LIS/LIMS, and middleware platforms. The specialist will lead and guide system validations, support change control, and collaborate with subject matter experts to define system requirements and translate them into technical specifications. The role also involves providing technical consultation to clients, gathering and documenting system requirements, creating and maintaining validation documentation, and leading testing activities for laboratory workflows and automation. Additionally, the specialist will oversee requirements gathering for middleware interface development, coordinate with project managers, ensure timely delivery of services, drive client satisfaction, and monitor system testing progress. Maintaining regulatory compliance and collaborating with other sites and cross-functional teams are also key aspects of this position. The role supports a culture of continuous improvement, quality, and productivity.

Requirements

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.
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

Knowledge of SDLC/GAMP is a plus.
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.

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.