Validation Specialist

Karwell Technologies

Thousand Oaks, CA

JOB DETAILS
SKILLS
Change Control, Computer Systems, Corrective and Preventative Action (CAPA) Systems, GMP (Good Manufacturing Practices), GxP, Laboratory Information Management System (LIMS), Laboratory Systems, Labware, Maintain Compliance, Process Validation, Regulations, Regulatory Compliance, System Validation, Validation Documentation, Validation Testing, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
18 days ago
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.

About the Company

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Karwell Technologies