Cognizant hiring CSV Validation Engineer , Lead (Life Sciences, Pharma IT Systems)

Cognizant Technology Solutions is hiring for:

1. CSV Validation Lead (Life Sciences, Pharma IT Systems) – Experience 8-12 years

Required Skills:

• Hands-on experience in End-to-End Validation of pharma equipment and software applications.
• Experience in Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Developing deliverables like URS, FRS, DQ, VMP, VP, RITM, IQ, OQ, PQ, VSR, SOPs for pharmaceutical equipment, facilities, and computerized systems used in GXP environments.
• Well-versed in V model, W model & SDLC Lifecycle.
• Exposure to Regulatory Audits and should be able to lead the projects.
• Preferred Experience in MES, EDMS, QMS.
• Knowledge of Agile, Waterfall model.

2. CSV Validation Engineer (Life Sciences, Pharma IT Systems) – Experience 5-8 years

Required Skills:

• Hands-on experience in End-to-End Validation of pharma equipment and software applications.
• Good understanding of CFR Part 11, GAMP 5, EU Annex 11.
• Experience in preparation and execution of validation documents like GAP Assessment, Validation Plan, URS, FRS, IQ, OQ, PQ, Traceability Matrix, and VSR.
• Should have worked in V model, W model & SDLC Lifecycle.
• Good understanding of QMS, GXP requirements.
• Exposure to Regulatory Audits.
• Preferred Experience in MES, SCADA, PLC/HMI, PCS, BMS, EMS, DHS, FMS.
• Knowledge of Agile, Waterfall model.

If suitable, share your profiles to:

• nisar.mulani@cognizant.com
• trupti.waje@cognizant.com
• hiral.rao@cognizant.com