Lab Instrumentation - Medical Device Validation Tester

at Cognizant in Springfield, Illinois, United States Job Description 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 We strive to provide flexibility wherever possible.

Based on this role's business requirements, this is a remote position open to qualified applicants in United States. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs. 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 We're excited to meet people who share our mission and can make an impact in a variety of ways.

Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

Salary and Other Compensation:

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:

Cognizant offers the following benefits for this position, subject to applicable eligibility requirements: 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. Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To view full details and how to apply, please login or create a Job Seeker account