CSV Lab Systems Validation Engineer

Cognizant; Sarasota (FL); Presencial; USD 75.000 - 105.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Holidays

Paid Time Off

401(k) Plan

Disability Insurance

Parental Leave

Employee Stock Purchase Plan

Descripción de la vacante

Cognizant is seeking a CSV validation professional in Florida to lead validation activities across pharmaceutical equipment, facilities and computerized systems within GLP, GMP and GCP environments. You will develop validation artifacts including URS, MVP, VP, IQ/OQ/PQ and traceability matrices while aligning with CSA, GAMP 5 and SDLC.

Strong documentation, communication and QA oversight are essential. Experience with Agile is a plus.

Formación

• Experience/ exposure to CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

Responsabilidades

• Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.

Conocimientos

CSV Validation

Regulatory Compliance

Quality Management

Technical Writing

Agile

Project Leadership

GAMP 5

SOP SDLC

CSA & Module Validation

Herramientas

Jira

ServiceNow

HP ALM

Descripción del empleo

Cognizant is seeking a CSV validation professional in Florida to lead validation activities across pharmaceutical equipment, facilities and computerized systems within GLP, GMP and GCP environments. You will develop validation artifacts including URS, MVP, VP, IQ/OQ/PQ and traceability matrices while aligning with CSA, GAMP 5 and SDLC.

Strong documentation, communication and QA oversight are essential. Experience with Agile is a plus.