CSV Engineer: Regulated Systems Validation Lead

Katalyst Healthcares & Life Sciences; Newark (DE); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst Healthcares & Life Sciences is seeking a Computer System Validation (CSV) Engineer to join our Newark, DE team. You will lead CSV activities for GxP systems, ensure compliance with FDA 21 CFR Part 11 and GAMP 5, and support audits and regulatory inspections throughout the system lifecycle.

Ideal candidates have a Bachelor’s degree in a related field, hands-on CSV experience, and strong documentation and communication skills to collaborate with IT, QA, and business teams.

Qualifications

• Experience with CSV lifecycle in regulated environments.
• Understanding of GxP validation and compliance.
• Ability to implement risk-based validation approaches.
• Strong documentation and communication skills.

Responsibilities

• Lead and support CSV activities for GxP systems, including validation planning, execution, and reporting
• Develop and review validation deliverables such as Validation Plans, URS, FS/DS, IQ, OQ, PQ protocols, and summary reports
• Ensure compliance with FDA 21 CFR Part 11, 21 CFR Part 820, and GAMP 5 guidelines
• Perform risk assessments to determine validation scope and testing requirements
• Support system implementation, upgrades, and changes through change control processes
• Collaborate with cross-functional teams (IT, QA, Validation, and business users)
• Maintain and review validation documentation to ensure accuracy and completeness
• Participate in audit readiness activities and support regulatory inspections
• Identify and resolve validation deviations, discrepancies, and non-conformances
• Ensure proper data integrity and security compliance across systems

Skills

CSV lifecycle

GxP validation

Risk-based validation

Documentation skills

Education

Bachelor's degree

Job description

Katalyst Healthcares & Life Sciences is seeking a Computer System Validation (CSV) Engineer to join our Newark, DE team. You will lead CSV activities for GxP systems, ensure compliance with FDA 21 CFR Part 11 and GAMP 5, and support audits and regulatory inspections throughout the system lifecycle.

Ideal candidates have a Bachelor’s degree in a related field, hands-on CSV experience, and strong documentation and communication skills to collaborate with IT, QA, and business teams.