Senior Validation Lead - GMP, CSV & CQ Expert

Katalyst CRO; Richmond (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks a Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment in the United States. You will plan, execute, review, and approve validation documentation for equipment, facilities, and computer systems while ensuring FDA/EMA/cGMP compliance.

You will mentor junior staff, support audits, and collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory groups to maintain data integrity and quality systems.

Qualifications

• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, CSV.
• Experience with FDA/EMA guidelines and data integrity basics.

Responsibilities

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ) for equipment, facilities, utilities, processes, and computerized systems.
• Author, review, and approve validation protocols, reports, risk assessments, and plans.
• Manage deviations, CAPAs, change controls, and support regulatory inspections.
• Mentor junior validation engineers and collaborate with QA, Manufacturing, and Regulatory teams.

Skills

Validation lifecycle

GMP compliance

Technical writing

Regulatory audits

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat

ValGenesis

TrackWise

MasterControl

Job description

Katalyst CRO seeks a Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment in the United States. You will plan, execute, review, and approve validation documentation for equipment, facilities, and computer systems while ensuring FDA/EMA/cGMP compliance.

You will mentor junior staff, support audits, and collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory groups to maintain data integrity and quality systems.