CSV Lead

Katalyst CRO; Greensboro (NC); Sur place; USD 150 000 - 190 000; Plein temps

Résumé du poste

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

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

CSV leadership

Regulatory compliance

Validation lifecycle

Risk assessment

Cross-functional collaboration

Formation

Bachelor's or Master's degree in related field

Outils

LIMS

MES

ERP (SAP)

QMS

DMS

SCADA

PLC/HMI

Description du poste

Job Description

We are seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

Job Description

We are seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

Responsibilities

• Lead end-to-end Computer System Validation (CSV) activities for GxP computerized systems.
• Develop and review Validation Plans, Validation Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Execute and oversee IQ, OQ, and PQ activities.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements.
• Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
• Perform risk assessments using GAMP 5 methodology.
• Manage deviations, CAPAs, change controls, and periodic reviews.
• Support software implementation, upgrades, migrations, and decommissioning projects.
• Coordinate validation activities with IT, Quality Assurance, Engineering, Manufacturing, and Business teams.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor junior CSV engineers and provide technical guidance.
• Maintain validation lifecycle documentation according to company SOPs.

Requirements:

• Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
• 8-12+ years of Computer System Validation experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Strong understanding of GxP regulations and computerized system validation.
• Experience validating enterprise systems such as:
  • LIMS.
  • MES.
  • ERP (SAP).
  • Laboratory Systems.
  • SCADA.
  • PLC/HMI.
  • Manufacturing Execution Systems.
  • Electronic Batch Records (EBR).
  • Quality Management Systems (QMS).
  • Document Management Systems (DMS).