Senior Validation Engineer - GxP & Equipment Qualification

Indivior PLC; Raleigh (NC); On-site; USD 88,000 - 105,000; Full time

Benefits offered by this job

Competitive PTO

Bonus program

401(k) matching

Health, Dental, Vision, Life” and Dis/

Tuition reimbursement

Stock Purchase Plan

Job summary

Indivior PLC is seeking a Senior Validation Engineer to lead validation activities at our Raleigh, NC site, ensuring alignment with global procedures and regulatory standards. You will drive qualification of equipment, processes, and environmental controls, while guiding a team and coordinating with cross-functional groups.

The role requires a Bachelor's in science/engineering and 5+ years of related experience, with ~10% travel and strong proficiency in MS Office and quality methodologies.

Qualifications

• Bachelor’s degree in science or engineering from an accredited university.
• Minimum five (5) years of experience in production, engineering, environmental monitoring, quality control, mechanical or related fields.
• Ability to learn new processes and equipment independently.
• Proficient in Microsoft Word and Excel.
• Travel: Approximately 10% travel.
• Knowledge of quality system methodologies (FMEA, Pareto Analysis, Six Sigma).

Responsibilities

• Author validation protocols (IQ/OQ/PQ) and final reports; write test scripts and user requirements.
• Execute requalification and validation protocols.
• Organize and maintain validation documentation.
• Track projects for timely delivery and regulatory compliance.
• Use Kaye Validator System or equivalent for validation tasks.
• Gown into aseptic areas and maintain qualified equipment systems.
• Lead installation, commissioning, and validation of process equipment.
• Manage changes, deviations, investigations, and CAPAs via Veeva Vault.

Skills

GxP compliance

Quality systems

Cross-functional collaboration

Documentation & records management

Change control

Education

Bachelor's degree in science or engineering

Tools

Kaye Validator System

Job description

Indivior PLC is seeking a Senior Validation Engineer to lead validation activities at our Raleigh, NC site, ensuring alignment with global procedures and regulatory standards. You will drive qualification of equipment, processes, and environmental controls, while guiding a team and coordinating with cross-functional groups.

The role requires a Bachelor's in science/engineering and 5+ years of related experience, with ~10% travel and strong proficiency in MS Office and quality methodologies.