Senior Validation Engineer – GMP Compliance Leader

Indivior in

Raleigh (NC)

On-site

USD 88,000 - 105,000

Full time

4 days ago

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Benefits offered by this job

Competitive PTO and company closure (H

Bonus program

Long-Term Incentive Plan

401(k) and profit sharing

Employee stock purchase plan

Comprehensive medical/dental/vision

Wellness programs and other perks

Job summary

Indivior is seeking a Senior Validation Engineer to lead validation activities at the Raleigh, NC site, ensuring adherence to FDA regulations and global procedures. The role includes developing, reviewing, and managing validation activities, including IQ/OQ/PQ protocols, risk assessments, and CAPA processes, with opportunities to influence cross-functional teams.

The ideal candidate will have a strong GMP/GXP background, 5+ years in relevant fields, and the ability to work in a fast-moving

Qualifications

Bachelor's degree in science or engineering from an accredited university.
Minimum of five years in production, engineering, environmental monitoring, quality control, or related fields.

Responsibilities

Author validation protocols (IQ/OQ/PQ) and final reports; write test scripts and user requirements.
Execute requalification/validation protocols and organize validation documentation.
Track projects for timely delivery and regulatory compliance.
Interact with FDA investigators regarding validation and compliance.