CSV Engineer – GxP Validation & Compliance

Katalyst CRO; Cambridge (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a Computer Systems Validation Engineer to ensure GxP computerized systems are validated and controlled in line with industry standards. The role covers on-prem and cloud-based applications, with responsibilities spanning risk assessment, documentation, and validation lifecycle management.

The position emphasizes leading CSV/CSA procedures, collaborating with IT and business units, and maintaining awareness of regulatory changes.

Qualifications

• Bachelor’s degree in Engineering, Computer Science or related discipline.
• 3-5+ years of CSV experience in an FDA regulated industry.
• Strong knowledge of cGMP and FDA 21 CFR Part 11 and EU Annex 11.
• Understanding of data integrity requirements and how to perform assessments.
• Experience qualifying on premises and externally hosted software systems (SaaS, PaaS, IaaS).
• Ability to work with and influence people at all levels on CSV/CSA and GxP compliance.
• Demonstrated experience managing complex validation projects and maintaining validation timelines.
• Understanding of change control and discrepancy investigations.

Responsibilities

• Provide CSV and CSA-based compliance guidance to IT, system owners, and stakeholders.
• Lead development and adherence to CSV/CSA procedures with risk-based approach.
• Generate, revise, and execute life cycle deliverables per GAMP 5 guidelines.
• Evaluate proposed systems for GxP impact and define CSA-based validation strategy.
• Review vendor documentation and perform independent verification for regulatory expectations.
• Support change control, deviation resolution, CAPA, and effectiveness checks.
• Manage decommissioning activities for retired systems.
• Assess IT service providers to ensure appropriate controls based on risk.
• Participate in project teams and communicate progress to stakeholders.
• Maintain knowledge of evolving regulatory requirements and assist audits.

Skills

CSV/CSA knowledge

Regulatory compliance

Communication skills

Technical writing

Mentoring

Project management

Initiative & self-motivation

Education

Bachelor's degree in Engineering, Computer Science or related discipline

Tools

LabWare LIMS

MasterControl

SAP

Blue Mountain

EMS

IT infrastructure components

Job description

Katalyst CRO is seeking a Computer Systems Validation Engineer to ensure GxP computerized systems are validated and controlled in line with industry standards. The role covers on-prem and cloud-based applications, with responsibilities spanning risk assessment, documentation, and validation lifecycle management.

The position emphasizes leading CSV/CSA procedures, collaborating with IT and business units, and maintaining awareness of regulatory changes.