Computer System Validation Specialist
Do you have Computer Systems Validation experience and want to work in our growing Environmental Sciences group?
Do you have an interest in science and want to be a part of the world's leading life sciences company?
Labcorp is a leading global life sciences company that includes contract research and developmental services to the pharmaceutical, medical technology, crop protection and chemical industries.
In our Environmental Sciences team, we are seeking a Laboratory Systems Validations Specialist - 12 month fixed term contract, 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 Directors, Lab Project Managers and IT shared services as well as external vendors.
This is a remote role that will require travel to our sites in Shardlow - Derbyshire, Huntingdon - Cambridgeshire and Eye - Suffolk.
Duties will include the following:
- 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 behaviour 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
- Responsible to develop and lead test efforts for a variety of laboratory workflow and physical automation and lab instrument software platforms
- Works with Testing Enablement and IT project managers and resources owners to coordinate resources for system test efforts
- 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.
- Coordinates the review, approval, and retention of validation documentation
Skills and experience:
- Bachelor of Science/Engineering or higher degree in a related area of study
- Background in information systems, data analysis, workflow analysis within the Environmental Sciences and pharmaceutical industry
- Experience with laboratory instrument operation and/or laboratory analysis applications.
- Ability to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory
- 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)
- Strong knowledge of 21 CFR Part 11 requirements is an added value
- Strong knowledge of lab workflow and processes
- Previous ownership in computer system validation (CSV) and/or software testing activities
What Labcorp can offer you:
- Competitive salary and a comprehensive benefits package, including health coverage and contributory pension
- Ability to work with a variety of different clients on wide ranging projects.
- Flexible working and career development opportunities
- Opportunity to work in a rapidly expanding department
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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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