CSV Engineer (Analyst II)

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

• The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing validation lifecycle management.

About The Job

• The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing validation lifecycle management.

Roles And Responsibilities

• Provide CSV and CSA-based compliance guidance to the IT function, system owners, and business stakeholders, applying a risk-based approach focused on patient safety, product quality, and data integrity.
• Lead the development, harmonization, implementation, and adherence to CSV and CSA procedures, ensuring validation effort is commensurate with system risk, intended use, and GxP impact.
• Generate/Revise/Execute system life cycle deliverables using a risk-based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable)
• Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA aligned validation strategy that balances compliance, efficiency, and business needs.
• Review and assess vendor supplied documentation and testing evidence, leveraging supplier activities where appropriate, and perform independent risk-based verification to ensure compliance with internal requirements and regulatory expectations.
• Support change control activities, deviation resolution, CAPA, and effectiveness checks for computer systems.
• Manage and execute decommissioning activities for retired or end of life systems.
• Ensure that suppliers of IT services and solutions are properly assessed to determine their level of compliance and ensure that appropriate controls are in place based on risk.
• Participate in project teams executing various validation projects and communicate project plans, status updates and progress against milestones to project team members.
• Maintain up to date knowledge of evolving regulatory requirements regarding computer systems and act as an information resource for the team and business stakeholders.
• Support internal and external audits and regulatory inspections.
• Perform other validation engineering duties as assigned.

Qualification

• Bachelor's degree in Engineering, Computer Science or related discipline.
• Must have 3-5+ years of CSV experience in an FDA regulated industry.
• Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11and EU Annex 11 regulations and standards.
• Understanding of data integrity requirements and how to perform assessments.
• Knowledge and experience with qualifying on premises and externally hosted (SaaS, PaaS, IaaS) software systems.
• Ability to work with and influence people at all levels in matters related to CSV,CSA and GxP compliance.
• Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements and timelines.
• Understanding of quality systems such as change control and discrepancy investigations.
• Experience working with IT for qualification of network and infrastructure.
• Demonstrated written and verbal communication skills.
• Proficient with Microsoft Office, particularly Word and Excel.
• High degree of initiative and self-motivation.
• Experience creating technical, written content.
• Ability to mentor team members and colleagues.

Preferred Qualifications

• Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components.