CSV Lead

Katalyst CRO; Cambridge (MA); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Cambridge, MA is seeking an experienced CSV Lead to oversee validation activities for GxP computerized systems. The role requires deep expertise in CSV lifecycle management, FDA and global regulatory compliance, risk assessments, and cross-functional collaboration to ensure systems meet business and regulatory requirements.

You will develop and review Validation Plans, Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports, and you will lead IQ, OQ,

Formación

• Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
• 812+ 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:

Responsabilidades

• 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.

Conocimientos

CSV lifecycle management

FDA compliance

Risk assessments

Validation documentation

Cross-functional collaboration

IQ/OQ/PQ execution

Traceability matrices

GxP regulations

DMS/QMS/DMS

Educación

Bachelor's or Master's degree in Computer Science/IT/Biotech/Pharma/Engineering

Herramientas

LIMS

MES

ERP SAP

SCADA

PLC/HMI

QMS

DMS

Descripción del empleo

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.
• 812+ 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).