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Medical Device Validation Tester - Lab Instrumentation

Cognizant

About the role As a Lab Instrumentation / Medical Device Validation Tester, you will make an impact by ensuring laboratory instrumentation software is validated, compliant, and aligned with regulatory requirements and internal SOPs. You will be a valued member of the validation team and work collaboratively with cross‑functional stakeholders including IT, Quality Assurance, and Laboratory Operations. In this role, you will: Validate software installed on laboratory instruments in accordance with EMA and GxP regulatory standards Develop and execute validation protocols, test cases, and supporting documentation Capture and document software requirements, configurations, and validation evidence Conduct risk assessments and support validation lifecycle activities Collaborate with IT, QA, and lab teams to ensure alignment with PPD IT software management SOPs and regulatory expectations Work model At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work‑life balance through our various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring 5 days per week at a client location in Highland Heights, Kentucky. The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations. What you need to have to be considered: 6+ years of experience in instrument or medical device validation within a regulated (GxP) environment Strong knowledge of validation lifecycle, including protocol development, execution, and documentation Experience with EMA regulatory guidelines and pharmaceutical or medical device compliance standards Proven technical writing skills, including authoring test cases and validation documentation Experience performing risk assessments and ensuring documentation accuracy and audit readiness These will help you stand out: Prior experience validating laboratory instrumentation software Familiarity with IT SOP alignment and software lifecycle processes in regulated environments Strong collaboration skills working across IT, QA, and lab operations teams High attention to detail with a focus on compliance and quality Ability to create infrastructure diagrams and data flow documentation Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship. Please note, this role is not able to offer visa transfer or sponsorship now or in the future. Salary and Other Compensation: Applications will be accepted until May 30th, 2026. The annual salary for this position is between $71,100 to $112,500 depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans. Benefits: Medical/Dental/Vision/Life Insurance Paid holidays plus Paid Time Off 401(k) plan and contributions Long‑term/Short‑term Disability Paid Parental Leave Employee Stock Purchase Plan Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law. #J-18808-Ljbffr Cognizant

Vacancy posted more than 2 months ago

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