Lab Instrumentation - Medical Device Validation Tester

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.

Responsibilities

• 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

Requirements

• 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
• Prior experience validating laboratory instrumentation software
• Familiarity with IT SOP alignment and software lifecycle processes in regulated environments
• Proven technical writing skills, including authoring test cases and validation documentation
• Experience performing risk assessments and ensuring documentation accuracy and audit readiness

Qualifications

• 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

Skills

• Highly organized and detail-oriented
• Excellent communication and interpersonal skills
• Proficient in Microsoft Office Suite

Benefits

• 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