Quality Engineer

Job Description
Our client, a world leader in diagnostics and life sciences, is looking for a " Quality Engineer" based out of Hillsboro, OR.

Job Duration: Long term Contract (Possibility Of Further Extension)

Pay Rate: $65/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

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.

Key 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.

Qualifications:

• 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.

Top Skills:

• Qualification & Validation (Equipment, Process, Cleaning, CSV)
• cGMP Compliance & Quality Systems
• Risk Assessment, Change Control, and Deviation Management

If interested, please send us your updated resume at

hr@dawarconsulting.com/kavitha@dawarconsulting.com

Skill Set
Validation, cGMP