Labcorp · 16 hours ago
Laboratory Systems Validation Specialist I
Indianapolis, IN
Full-time
Onsite
Mid Level
3+ years expLabcorp is one of the world's largest drug development services companies, and they are seeking a Laboratory Systems Validation Specialist I to perform validation activities for laboratory instruments and systems. The role involves close coordination with various stakeholders to ensure effective validation processes and compliance with regulatory standards.
BiotechnologyHealth CareHospitalLife ScienceMedicalPrecision Medicine
Responsibilities
The candidate should possess experience with laboratory instrument operation and/or laboratory analysis applications
Provides insight and guidance while leading system validations for instrument, software applications (particularly customized applications) and other laboratory systems
Take lead in writing and maintain records of all required system validation deliverables including, but not limited to, validation plans, requirement specifications, test plan, traceability matrix, summary reports, etc
Provide operational support through support of change control process for laboratory instrument and systems
Responsible to participate in the assessment and description of, in close collaboration with the laboratory subject matter experts (SME), the expected behavior of the systems to automate some process steps and be able to translate them into formal requirements to whomever relevant (IT, person in charge of configuring rules...). These requirements will include potential changes/set-up needs outside of the middleware such as LIS to have the expected data workflow thanks to higher level understanding of data flow across systems
Provides technical consults, as needed, for both internal and external clients
Ensures the collection of system requirements through communication with stakeholders and documentation of system requirements according to specified methodologies
Owns and produces appropriate validation documentation. The ideal candidate possesses experience within a GxP and CAP/CLIA environment. Experience with SDLC and/or GAMP is a plus
Responsible to develop and lead test efforts for a variety of laboratory workflow and physical automation and lab instrument software platforms
Responsible to lead requirement gathering efforts for middleware interface development efforts
Works with Testing Enablement and IT project managers and resources owners to coordinate resources for system test efforts
Responsible for driving overall performance and delivery of on-time services
Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business
Responsible for ensuring client satisfaction
Responsible to monitor execution of system testing according to specified metrics, identifies and resolves issues and challenges; escalates issues as needed
Accountable for the pre-QA evaluation and treatment of system test results, ensuring appropriate and complete test packages for each system effort in which he/she is involved
Responsible for timely and efficient work output within each functional area in accordance with Covance quality standards
Responsible to balance operational support assignment with at least one active project assignments
Ensures resources are sufficient to meet established performance and quality goals
Ensures regulatory compliance
Collaborate between the local department unit and counterparts at other sites and with other functional areas
Perform duties of qualification specialist roles as needed in times of high customer demand
Coordinates the review, approval, and retention of validation documentation
Provides written and verbal reports to project managers and/or GLSS leadership
Responsible to execute all HR and training-related personnel tasks as defined by the company and department
Provide a monthly report to the Manager
Individual is responsible for maintaining his/her complete up-to-date training file. Individual is responsible for ensuring he/she is trained, and training is documented prior to performing a task. Individual is accountable for any deficiencies found in his/her training file
Support a culture of continuous improvement, quality, and productivity
Qualification
Required
Bachelor of Science/Engineering or higher degree in a related area of study
Background in information systems, data analysis, workflow analysis within the pharmaceutical industry
Ability to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory
3 to 5 years' experience in a regulated Computer System Validation (CSV), Laboratory System Analyst or Laboratory System Validations role (or similar experience)
Experience in IT/Computer validation (to leverage important inputs on how to manage 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 is an added value
Strong knowledge of lab workflow and processes
Previous ownership in computer system validation (CSV) and/or software testing activities
Fluency in English, knowledge of French is a plus
Preferred
Experience in audits is a plus but not required
Experience with SDLC and/or GAMP is a plus
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan
Company
Labcorp
Labcorp specializes in providing physicians with laboratory tests.
10001+ employees
H1B Sponsorship
Labcorp has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.85B2024-09-16Post Ipo Debt· $2B
2019-06-04Post Ipo Debt· $850M
1988-07-15IPO
Leadership Team
Adam Schechter
President and Chief Executive Officer
Bill Haas
SVP, Northeastern US and Canada, Labcorp Diagnostics
Recent News
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