Validation Specialist

Roles & Responsibilities

• Support cleaning validation activities, protocol execution, sampling, and documentation.
• Perform temperature mapping and requalification of controlled temperature units.
• Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
• Support commissioning, installation, and qualification of new or modified equipment.
• Absorb equipment troubleshooting alongside Engineering and Operations.
• Generate validation documentation following cGMP, GDP, and SOP requirements.
• Sustain validation lifecycle activities, change controls, investigations, and CAPAs.
• Participate in audit readiness and regulatory inspection support.