Job Details:
- Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- Experience of CSV Validation in any one of the Lab systems is must.
- Should worked in pharmaceutical domain and its related knowledge is must
- Good communication and technical writing skills are a must
- Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
- Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
- CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
- To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
- Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
- Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
- Exposure to Regulatory Audits and Remediation activities
- Ensure the CSV artefacts are in line and meets regulatory requirements
- Preferred Experience in Agile Development
- Knowledge on working in Jira / Service Now
- Adaptation to AI is preferred.
Testing (in addition to above)
- Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
- Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
- Knowledge on working in Jira, HP ALM or any automation testing tools.
*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 who can make an impact in a variety of ways. Don't hesitate to apply—even if you only meet the minimum requirements. Think about your transferable experiences and unique skills that make you stand out.
Salary and Other Compensation:
Applications will be accepted until Aug 30, 2026,
The annual salary for this position is between $ 75,000 - $ 123,000 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.
Acerca de Cognizant
Cognizant (Nasdaq: CTSH) es un creador de soluciones de IA y proveedor de servicios tecnológicos que conecta la inversión en IA con el valor empresarial mediante el desarrollo de soluciones de IA full‑stack para sus clientes. Su profundo conocimiento de la industria, junto con su experiencia en procesos e ingeniería, permite incorporar el contexto único de cada organización en sistemas tecnológicos que amplifican el potencial humano, generan resultados tangibles y mantienen a las empresas a la vanguardia en un entorno en constante cambio. Más información en cognizant.ai o @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.
