Senior CSV Lead: Regulated Systems Validation & Compliance

Katalyst CRO; Greensboro (NC); In loco; USD 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO seeks an experienced CSV Lead to oversee validation activities for GxP computerized systems. The role requires extensive experience in CSV lifecycle management, FDA/global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

The ideal candidate will mentor junior CSV engineers, coordinate validation with IT, QA, and manufacturing, and support audits and inspections

Competenze

• 8–12+ years of CSV experience in pharma/biotech/medical devices or life sciences.
• GxP regulations and CSV validation expertise required.
• Experience validating enterprise systems and managing lifecycle documentation.

Mansioni

• Lead end-to-end CSV activities for GxP computerized systems.
• Develop and review Validation Plans, Protocols, Risk Assessments, and VSRs.
• Execute IQ, OQ, and PQ activities to ensure validated state.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5 and global regs.
• Review URS, FS, DS; perform risk assessments using GAMP 5.
• Manage deviations, CAPAs, change controls, and periodic reviews.
• Support software implementation, upgrades, migrations, and decommissioning.
• Coordinate validation with IT, QA, Engineering, Manufacturing, and Business units.
• Support audits and regulatory inspections; mentor junior CSV engineers.
• Maintain validation lifecycle docs per SOPs.

Conoscenze

CSV leadership

Regulatory compliance

Validation lifecycle

Risk assessment

Cross-functional collaboration

Formazione

Bachelor's or Master's degree in related field

Strumenti

LIMS

MES

ERP (SAP)

QMS

DMS

SCADA

PLC/HMI

Descrizione del lavoro

Katalyst CRO seeks an experienced CSV Lead to oversee validation activities for GxP computerized systems. The role requires extensive experience in CSV lifecycle management, FDA/global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

The ideal candidate will mentor junior CSV engineers, coordinate validation with IT, QA, and manufacturing, and support audits and inspections