Senior Validation Engineer, GMP/CSV Expert

indivior; Raleigh (NC); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Indivior is seeking a Senior Validation Engineer to lead the development, implementation and continuous improvement of validation practices at the Raleigh, NC site, aligning with global procedures to ensure FDA compliance and regulatory adherence.

The role requires expertise in qualification of equipment and processes, involvement in FAT/SAT, writing IQ/OQ/PQ protocols, and driving CAPA and change management within GMP environments.

Qualifikationen

• Bachelor's degree in science or engineering from an accredited university.
• Minimum of five years of experience in production, engineering, environmental monitoring, quality control, mechanical or related fields.
• Proficient in Microsoft Word and Excel.
• Travel: Approximately 10%.
• Ability to learn new processes and equipment independently.

Aufgaben

• Lead qualification and requalification of equipment and processes at the Raleigh site.
• Develop, review, execute, and manage validation activities aligned with regulatory requirements.
• Author IQ/OQ/PQ protocols and final reports; write test scripts and user requirements.
• Organize and maintain validation documentation; track projects for timely delivery.
• Manage changes, deviations, investigations, and CAPAs using Veeva Vault.
• Collaborate with FDA interactions regarding cleaning validation and equipment qualifications.
• Drive continuous improvement of GMP validation practices and risk-based approaches.

Kenntnisse

GxP compliance

Change management

Process validation

CAPA management

Data integrity

Ausbildung

Bachelor's degree in science or engineering

Tools

Kaye Validator System

Veeva Vault

Jobbeschreibung

Indivior is seeking a Senior Validation Engineer to lead the development, implementation and continuous improvement of validation practices at the Raleigh, NC site, aligning with global procedures to ensure FDA compliance and regulatory adherence.

The role requires expertise in qualification of equipment and processes, involvement in FAT/SAT, writing IQ/OQ/PQ protocols, and driving CAPA and change management within GMP environments.