Get ready to redefine what is possible and discover your extraordinary potential. Here at Labcorp, you will have the opportunity to personally advance healthcare and are effective in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you will be empowered to own your career journey with mentoring, training, and personalized development planning. 

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

The Company - LabCorp

As one of the world's largest and most comprehensive drug development services companies, LabCorp has helped pharmaceutical and biotech companies develop one-third of all prescription drugs in the marketplace today.

The Position

We are seeking a Lab Systems Validations Specialist to perform activities related to the effective validation of laboratory instruments, middleware, and other specific systems. Responsibilities include close coordination with the Laboratory Systems Implementation Specialists, Laboratory Global Directors, Lab Project Managers, and IT shared services as well as external vendors.

This position with be based in Indianapolis, IN.

Duties will include the following:

Strategy and Business Development:

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 systemsProvides technical consults, as needed, for both internal and external clients

Leadership duties and responsibilities:

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 platformsResponsible 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 effortsResponsible for driving overall performance and delivery of on-time servicesMaintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.Responsible for ensuring client satisfaction

Performance Monitoring and Evaluation:

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 goalsEnsures regulatory complianceCollaborate between the local department unit and counterparts at other sites and with other functional areas

Duties and Responsibilities General:

Perform duties of qualification specialist roles as needed in times of high customer demand.Coordinates the review, approval, and retention of validation documentationProvides written and verbal reports to project managers and/or GLSS leadershipResponsible to execute all HR and training-related personnel tasks as defined by the company and departmentProvide a monthly report to the ManagerIndividual 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

Background and requirements:

Bachelor of Science/Engineering or higher degree in a related area of studyBackground in information systems, data analysis, workflow analysis within the pharmaceutical industryAbility to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory3 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 environmentStrong knowledge of 21 CFR Part 11 requirements and CAP/CLIA regulations is an added valueStrong knowledge of lab workflow and processesPrevious ownership in computer system validation (CSV) and/or software testing activitiesExperience in audits is a plus but not requiredFluency in English, knowledge of French is a plus

Thrive personally and professionally at Labcorp

Working at Labcorp, you will continue to grow in our learning-based culture, so you will know how to expertly respond and adapt as the industry continues to evolve. Here, you will put your education to work as you play a meaningful role in advancing healthcare and making a difference in people’s life.

In addition, Labcorp offers great benefits, global experience, and the opportunity to work independently within a collaborative environment.

Get to know Labcorp

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.

Here, you can join our more than 75,000 employees, serving clients in more than one hundred countries, as we work together to make a real impact on people’s lives.

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:

As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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.

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