The Position

Lab Systems Validations Specialist (Remote)

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. 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 systems

• Provides 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 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

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 goals

• Ensures regulatory compliance

• Collaborate 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 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

Background and requirements:

• 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 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 is an added value

• Strong knowledge of lab workflow and processes

• Previous ownership in computer system validation (CSV) and/or software testing activities

• Experience in audits is a plus but not required

• Fluency in English, knowledge of French is a plus

• Up to 10% travel required to Switzerland

Thrive personally and professionally at Labcorp

Working at Labcorp, you'll continue to grow in our learning-based culture so you'll know how to expertly respond and adapt as the industry continues to evolve. Here, you'll 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 team-oriented 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 100 countries, as we work together to make a real impact on people's lives.

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.

We encourage all to apply

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