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.
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