Quality Engineer

Dawar Consulting•Hillsboro, OR

14d

About The Position

The Quality Validation Engineer/Specialist will provide quality oversight and guidance for the site’s qualification and validation program, ensuring compliance with cGMP and quality standards.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field.
5–10 years of experience in the biopharmaceutical or pharmaceutical industry with focus on validation or quality assurance.
Strong knowledge of qualification/validation principles and lifecycle approach.
In -depth understanding of cGMPs and health authority expectations.
Excellent analytical, problem -solving, and communication skills.
Ability to work effectively across functions and adapt to changing priorities.
Qualification & Validation (Equipment, Process, Cleaning, CSV)
cGMP Compliance & Quality Systems
Risk Assessment, Change Control, and Deviation Management

Responsibilities

Provide quality oversight of qualification and validation activities for equipment, facilities, utilities, manufacturing processes, cleaning, sterilization, analytical methods, and computerized systems.
Review, assess, and approve validation and qualification documentation, including protocols, reports, and change controls.
Evaluate and approve changes impacting validated state and participate in deviation assessments.
Ensure adherence to internal quality system requirements and regulatory expectations.
Collaborate cross -functionally to drive compliant, consistent, and efficient validation practices.
Apply sound technical judgment in resolving complex quality and validation issues.