What are the responsibilities and job description for the Computer system validation Engineer position at Kasmo?
Key Responsibilities:
- Author and execute validation deliverables:
- Validation Plans, URS, FS/DS, Risk Assessments, Traceability Matrices
- IQ/OQ/PQ protocols and Validation Summary Reports
- Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11, and internal SOPs
- Validate GxP systems (ERP, LIMS, MES, SCADA, BMS) across their lifecycle
- Participate in implementations, upgrades, periodic reviews, and re-validations
- Manage deviations, CAPAs, and change controls
- Provide CSV training and support audit preparedness
- Maintain alignment with Data Integrity (ALCOA ) principles
Required:
- Bachelor’s in Engineering, Computer Science, or Life Sciences
- 2–5 years of CSV experience in GMP-regulated pharma environments
- Strong knowledge of GxP regulations, CSV methodologies, and regulated systems
- Proficiency in technical documentation and cross-functional collaboration
