About the role
As a Senior Validation Test Lead – Lab Instrumentation / Medical Devices, you will make an impact by ensuring regulatory compliance and validation of software used in medical laboratory instrumentation. You will be a valued member of the quality and compliance team and work collaboratively with cross-functional stakeholders, including regulatory affairs, engineering, and client teams.
In this role, you will:
• Lead the development and execution of validation and testing strategies for regulated software systems
• Document and validate instrument software in accordance with EMA guidelines and GxP requirements
• Perform risk assessments and proactively communicate risks to stakeholders
• Develop validation test cases, software specifications, and supporting documentation (including infrastructure and data flow diagrams)
• Collaborate with cross-functional teams to ensure seamless integration of compliance requirements
Work model
At Cognizant, we strive to provide flexibility wherever possible and support a healthy work-life balance through various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring full-time presence at a client or Cognizant office in Highland Heights, Kentucky.
The working arrangements for this role are accurate as of the date of posting. This may change based on project and business requirements.
What you need to have to be considered
• Proven lead-level experience in lab instrumentation or medical device software validation within a regulated (GxP) environment
• Strong knowledge of EMA guidelines, validation lifecycle, and compliance standards
• Expertise in technical documentation, validation test case creation, and specification writing
• Experience conducting risk assessments and validation lifecycle documentation
• Strong communication and stakeholder management skills across cross-functional teams
These will help you stand out
• Experience in pharmaceutical or medical device industry environments
• Familiarity with IT SOPs and regulatory audit readiness
• Proven ability to lead teams and mentor members in validation best practices
• Experience driving process improvements in testing frameworks and tools
• Exposure to automation or innovative testing approaches in regulated environments
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
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*
Sobre nosotros:
Cognizant (NASDAQ: CTSH) es un arquitecto de soluciones de IA y proveedor de servicios tecnológicos que traduce la inversión en inteligencia artificial en valor empresarial real mediante soluciones de IA de stack completo adaptadas a cada cliente. Su profundo conocimiento de la industria, los procesos y la ingeniería le permite integrar el contexto único de cada organización en sistemas tecnológicos que amplifican el potencial humano, generan un impacto real en el negocio y mantienen a las grandes empresas globales un paso adelante en un mundo en constante cambio. Para más información, visita www.cognizant.es o síguenos en @cognizant.
Información adicional de empleo
La información de compensación es precisa a la fecha de esta publicación. Cognizant se reserva el derecho de modificar esta información en cualquier momento, sujeto a la legislación aplicable.
Es posible que se requiera que los solicitantes asistan a entrevistas en persona o por videoconferencia. Además, es posible que se requiera que los candidatos presenten su identificación actual emitida por el estado o gobierno durante cada entrevista.
Cognizant es un empleador que ofrece igualdad de oportunidades. Tu solicitud y candidatura no serán consideradas en base a raza, color, sexo, religión, credo, orientación sexual, identidad de género, origen nacional, discapacidad, información genética, embarazo, condición de veterano o cualquier otra característica protegida por las leyes federales, estatales o locales.
Si tienes una discapacidad que requiere adaptaciones razonables para buscar una vacante de trabajo o enviar una solicitud, puedes enviar un correo electrónico a [email protected] con tu solicitud e información de contacto.
