Quality Validation Specialist - Pharmaceutical

MUST BE ON W2 - NO THIRD PARTY RECRUITERS OR SUBVENDING PERMITTED

Quality Validation Specialist

Location : Hillsboro, OR (Onsite)

Duration : 12 months (possible extension)

Schedule : Monday–Friday, standard business hours

Overview

We are seeking a Quality Validation Specialist to join a leading biopharmaceutical manufacturing organization responsible for producing commercial and pipeline drug products. This role provides quality oversight for qualification and validation activities across equipment, facilities, utilities, and GMP systems to ensure compliance with internal standards and regulatory expectations.

Key Responsibilities

• Provide quality oversight of qualification and validation activities related to equipment, facilities, utilities, manufacturing processes, cleaning, sterilization, and analytical methods.
• Ensure compliance with internal quality systems, cGMPs, and regulatory requirements.
• Review, assess, and approve qualification and validation documentation, deviations, and change controls.
• Guide internal stakeholders on best practices for consistent, compliant execution of validation activities.
• Evaluate the impact of changes on the validated state and ensure appropriate documentation.
• Collaborate cross-functionally to resolve technical and quality issues requiring analytical judgment.

Must-Have Qualifications

Nice-to-Have

Why Join

In simple terms — this person is a Quality Validation Specialist , which means they make sure all the equipment, systems, and processes used to make medicines actually work the way they're supposed to — safely, reliably, and in compliance with strict health regulations.