Senior Validation Engineer - GMP Compliance & QA Leadership

Katalyst CRO; Cincinnati (OH); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

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

The role requires mentoring junior validation engineers and collaborating with Engineering, QA, Manufacturing, and Regulatory teams to support

Formación

• Bachelor's degree required in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry or related fields.
• 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.

Responsabilidades

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

Conocimientos

GMP experience

Technical writing

Validation strategy

Cross-functional collaboration

Mentoring

Educación

Bachelor's degree in Engineering or Life Sciences

Herramientas

MES

LIMS

SCADA

PLC

ERP

TrackWise

MasterControl

Kneat

ValGenesis

Descripción del empleo

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

The role requires mentoring junior validation engineers and collaborating with Engineering, QA, Manufacturing, and Regulatory teams to support