GMP Validation Lead | CQ & CSV Expert

Katalyst CRO; Jackson (MS); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Katalyst CRO in the United States is seeking a Senior Validation Specialist to lead qualification and validation efforts in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems in accordance with FDA, EMA, and cGMP regulations.

The role requires 5+ years of GMP validation experience, strong IQ/OQ/PQ knowledge, risk assessments, and robust technical writing.

Qualifikationen

• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, Computer System Validation (CSV).
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Aufgaben

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ) for equipment, facilities, utilities, processes, and computer systems.
• Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
• Execute validation activities for equipment, processes, cleaning, utilities, facilities, and computer systems.
• Support commissioning and qualification activities for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, QA, Manufacturing, Automation, Regulatory teams.
• Mentor junior validation engineers and specialists.

Kenntnisse

DQ/IQ/OQ/PQ

Validation lifecycle

CSV

Risk assessments

Change control

CAPA

Technical writing

Ausbildung

Bachelor’s degree in Engineering/Life Sciences/Pharmacy/Chemistry

Tools

Kneat

ValGenesis

TrackWise

MasterControl

MES

LIMS

SCADA

PLC

ERP

Jobbeschreibung

Katalyst CRO in the United States is seeking a Senior Validation Specialist to lead qualification and validation efforts in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems in accordance with FDA, EMA, and cGMP regulations.

The role requires 5+ years of GMP validation experience, strong IQ/OQ/PQ knowledge, risk assessments, and robust technical writing.