Laboratory Systems Validation Specialist I at Labcorp

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

System Validation, Laboratory Instruments, LIS/LIMS, Middleware Platforms, Change Control, Technical Requirements, Requirements Gathering, Validation Documentation, GxP, CAP/CLIA, SDLC/GAMP, Testing Activities, Data Integrity, 21 CFR Part 11, Workflow Analysis, Client Relationship Management

Industry

Hospitals and Health Care

Description

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 (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 Preferred Qualifications 1 or more years experience of knowledge of lab workflow and processes 1 or more years experience in software testing or audits 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 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. For more detailed information, please click here. 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. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, 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. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

Responsibilities

This role involves providing technical and operational support for laboratory instruments, LIS/LIMS, and middleware platforms, while leading system validations and supporting change control processes. Key duties include gathering and documenting system requirements, creating validation documentation, and leading testing activities for laboratory workflows and automation.