Qualifications

• 10+ years in Computer System Validation (CSV) within Pharma, Biotech, Medical Device, or Life Sciences
• Strong knowledge of the GxP validation lifecycle and risk-based validation methods
• Hands-on experience with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports
• In-depth understanding of 21 CFR Part 11, GAMP5, FDA regulations, and data integrity standards
• Proficiency in managing deviations, CAPAs, change control, and conducting risk assessments
• Effective technical documentation capabilities and project leadership skills
• Experience engaging with cross-functional teams in regulated settings
• Familiarity with laboratory systems like LIMS, CDS, ELN, or SDMS and manufacturing systems such as MES, ERP

Responsibilities

• Lead and manage CSV activities across regulated Life Sciences projects
• Develop and review validation plans, protocols, and documentation
• Conduct validation lifecycle activities including URS, FS/DS, IQ, OQ, PQ, UAT, and RTM
• Perform risk assessments to ensure compliance with GxP requirements
• Support validation of GxP computerized and laboratory systems, manufacturing systems, and enterprise applications
• Manage deviations, CAPA, change controls, and validation-related investigations
• Coordinate with QA, IT, Engineering, Manufacturing, and Business teams to provide technical leadership
• Ensure adherence to FDA regulations, GAMP5 standards, and data integrity requirements
• Support audits, inspections, and readiness activities
• Manage project timelines and deliverables along with validation documentation

Benefits

• Comprehensive health insurance options
• Retirement savings plan with company match
• Opportunities for professional development and training
• Flexible work arrangements
• Paid time off and holiday schedule