Senior GMP Validation Lead - IQ/OQ/PQ Expert

Katalyst CRO; Baltimore (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring FDA, EMA, and cGMP compliance.

You will collaborate with Engineering, QA, Manufacturing, and Regulatory teams, mentor junior staff, and support regulatory inspections and audits to uphold data integrity and

Qualifications

• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, process validation, equipment qualification, cleaning validation, CSV, risk assessments, change control and CAPA.

Responsibilities

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ).
• Author, review, and approve validation documents and plans.
• Execute validation activities for equipment, processes, utilities, and computerized systems.

Skills

Validation lifecycle

IQ/OQ/PQ

Risk assessments

Change control

FDA/EMA knowledge

Education

Bachelor's degree in a relevant field

Tools

Kneat

ValGenesis

TrackWise

MasterControl

MES

LIMS

SCADA

PLC

ERP

Job description

Katalyst CRO is seeking a Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring FDA, EMA, and cGMP compliance.

You will collaborate with Engineering, QA, Manufacturing, and Regulatory teams, mentor junior staff, and support regulatory inspections and audits to uphold data integrity and