Senior CSV Engineer: Lead Validation for GxP Systems

Katalyst CRO; Fort Smith (AR); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Fort Smith, Arkansas, seeks a Senior CSV Engineer to lead validation activities for regulated computer systems across pharma, biotech, and medical device manufacturing. You will guide validation strategy, develop IQ/OQ/PQ protocols, and ensure ALCOA+ data integrity across systems such as LIMS, MES, and ERP.

Responsibilities include coordinating cross-functional teams, supporting audits, and driving process improvements while mentoring junior engineers to uphold regulatory

Formación

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 510+ years of experience in Computer System Validation (CSV) or validation engineering.
• Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
• Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Strong understanding of risk-based validation and data integrity principles.
• Experience supporting regulatory audits and inspections.

Responsabilidades

• 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.

Conocimientos

CSV validation leadership

Regulatory compliance

GxP knowledge

IQ/OQ/PQ execution

Risk-based validation

Data integrity ALCOA+

Stakeholder collaboration

Team mentorship

Educación

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

Herramientas

LIMS

MES

ERP

Laboratory systems

Descripción del empleo

Katalyst CRO in Fort Smith, Arkansas, seeks a Senior CSV Engineer to lead validation activities for regulated computer systems across pharma, biotech, and medical device manufacturing. You will guide validation strategy, develop IQ/OQ/PQ protocols, and ensure ALCOA+ data integrity across systems such as LIMS, MES, and ERP.

Responsibilities include coordinating cross-functional teams, supporting audits, and driving process improvements while mentoring junior engineers to uphold regulatory