Validation Specialist

Katalyst CRO; Thousand Oaks (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO in Thousand Oaks, CA, seeks a Validation Lead to drive Labware LIMS 8 validation projects and ensure GXP compliance.

You will author and review IQ/OQ/PQ, RTM, and validation documentation, support audits and inspections, and oversee validation testing activities.

The role emphasizes CSV, GAMP 5, and enterprise GMP systems, with a proactive approach to risk, change control, and quality assurance.

Qualifications

• Lead validation activities for Labware LIMS 8 implementation.
• Author and review IQ/OQ/PQ, RTM, and validation documentation.
• Ensure compliance with GXP, CSV, and regulatory standards.
• Support audits, inspections, and validation testing activities.

Responsibilities

• Lead validation activities for Labware LIMS 8 implementation.
• Author and review IQ/OQ/PQ, RTM, and validation documentation.
• Ensure compliance with GXP, CSV, and regulatory standards.
• Support audits, inspections, and validation testing activities.

Skills

Labware LIMS

CSV

GXP/GMP

GAMP5

IQ/OQ/PQ Docs

RTM

Validation Strategy

Audit readiness

Deviation/CAPA/Change

Lab Systems Validation

Job description

• Lead validation activities for Labware LIMS 8 implementation
• Author and review IQ/OQ/PQ, RTM, and validation documentation
• Ensure compliance with GXP, CSV, and regulatory standards
• Support audits, inspections, and validation testing activities.

Responsibilities

• Lead validation activities for Labware LIMS 8 implementation
• Author and review IQ/OQ/PQ, RTM, and validation documentation
• Ensure compliance with GXP, CSV, and regulatory standards
• Support audits, inspections, and validation testing activities.

Required Skills:

• Labware LIMS (Labware 8 Preferred)
• Computer System Validation (CSV)
• GXP / GMP Environment
• GAMP 5 & Regulatory Compliance
• IQ / OQ / PQ Documentation
• Requirements Traceability Matrix (RTM)
• Validation Strategy & Execution
• Audit Readiness & Inspection Support
• Deviation, CAPA & Change Control Management
• Laboratory Systems & Enterprise GMP Systems Validation.