Lead CSV Engineer: Regulated Systems Validation Expert

Katalyst CRO; St. Louis (MO); In loco; USD 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a Senior CSV Engineer to lead validation of GxP-regulated computerized systems (LIMS, MES, ERP, ELN, CDS) in a regulatory-driven environment. You will guide validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

You will mentor junior engineers, collaborate with IT, QA, and engineering, and drive continuous improvement of validation templates and standards for audits and inspections.

Competenze

• Bachelor's degree required in Engineering, Computer Science, Life Sciences, or related field.
• 510+ years of experience in Computer System Validation (CSV) or validation engineering.
• Experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Hands-on validation of LIMS, MES, ERP, or laboratory systems.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Experience supporting regulatory audits and inspections.

Mansioni

• Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
• Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
• Define and implement risk-based validation strategies for computerized systems.
• Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
• Support system implementations, upgrades, and decommissioning activities from a validation perspective.
• Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
• Lead change control assessments and determine validation impact of system changes.
• Ensure data integrity (ALCOA+) compliance across validated systems.
• Support audits and regulatory inspections by providing validation documentation and system justification.
• Mentor and guide junior CSV engineers and validation team members.
• Drive continuous improvement of validation processes, templates, and standards.
• Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.

Conoscenze

Leadership

SME

Analytical

Regulatory compliance

Risk assessment

Formazione

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field

Strumenti

LabWare

SAP

Oracle

Veeva

TrackWise

Empower

Descrizione del lavoro

Katalyst CRO is seeking a Senior CSV Engineer to lead validation of GxP-regulated computerized systems (LIMS, MES, ERP, ELN, CDS) in a regulatory-driven environment. You will guide validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.

You will mentor junior engineers, collaborate with IT, QA, and engineering, and drive continuous improvement of validation templates and standards for audits and inspections.