Laboratory Systems Validation Specialist

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.

• Operate and support laboratory instruments, interfaces, LIS/LIMS, and middleware platforms (e.g., Data Innovations Instrument Manager, Siemens Centra Link).
• 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.
• 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.

• Monitor system testing progress and performance metrics; identify and escalated 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.

• 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.

• 1 or more years of experience or knowledge of lab workflow and processes.
• 1 or more years of experience in laboratory software testing such as Navify, FCS Express, Infinicyte.
• 1 or more years of experience supporting client audits by providing an overview of the system validation documentation.
• Experience in IT/Computer validation (to leverage inputs on workflow, data integrity, and event capture for system 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 clients at all levels of the organization, primarily within the laboratory.

• Medical, Dental, Vision, Life, STD/LTD coverage.
• 401(k) plan with company match.
• Paid Time Off (PTO) or Flexible Time Off (FTO).
• Tuition Reimbursement and Employee Stock Purchase Plan.
• For part‑time employees working less than 20 hours, eligibility for the 401(k) plan only.

Labcorp is proud to be an Equal Opportunity Employer. Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and the qualifications and merit of the individual. Qualified applicants receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy or related medical conditions), family or parental status, marital status, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.