GMP Validation Leader: Qualification & CSV Expert

Katalyst CRO; Frederick (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an experienced 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, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.

Responsibilities include leading DQ/IQ/OQ/PQ lifecycle, authoring validation documents, managing deviations and CAPAs, and collaborating with Quality

Qualifications

• Bachelor-level education in a relevant field is required.
• 5+ years of validation experience in GMP environments.
• Strong knowledge of IQ/OQ/PQ, Process Validation, equipment qualification, CSV.

Responsibilities

• Lead DQ, IQ, OQ, and PQ activities across equipment, facilities, and systems.
• Author, review, and approve validation protocols and reports.
• Manage deviations, investigations, CAPAs, and change controls related to validation.
• Support regulatory inspections and internal audits.

Skills

Validation lifecycle

Regulatory compliance

Documentation & writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field

Tools

Kneat

ValGenesis

TrackWise

MasterControl

Job description

Katalyst CRO is seeking an experienced 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, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.

Responsibilities include leading DQ/IQ/OQ/PQ lifecycle, authoring validation documents, managing deviations and CAPAs, and collaborating with Quality