Quality Engineer
Job DescriptionJob 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