Job Description

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

Quality Validation Specialist

Location: Hillsboro, OR (Onsite)

Duration: 12 months (possible extension)

Schedule: MondayFriday, 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

• Bachelors degree in Engineering, Life Sciences, or a related field.
• 510 years of experience in validation, quality, or technical operations within the pharmaceutical or biopharmaceutical industry.
• Strong understanding of qualification and validation principles , including process, cleaning, and equipment validation.
• Proven ability to interpret and apply cGMPs and quality system standards.
• Excellent analytical, communication, and decision-making skills.

Nice-to-Have

• Experience supporting GMP computerized systems and automated manufacturing environments.
• Familiarity with FDA and EMA validation expectations and industry guidance (e.g., ISPE, ASTM, PDA).
• Ability to manage multiple priorities and partner effectively across teams.

Why Join

• Contribute to the delivery of life-saving medicines in a world-class manufacturing environment.
• Collaborate with cross-functional experts in engineering, validation, and quality.
• Opportunity to work with advanced pharmaceutical technologies and global compliance standards.

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 theyre supposed to safely, reliably, and in compliance with strict health regulations.

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