More jobs:
Quality Engineer
Job in
Hillsboro, Washington County, Oregon, 97124, USA
Listed on 2026-03-03
Listing for:
Dawar Consulting, Inc.
Full Time
position Listed on 2026-03-03
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
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
Skill Set
Validation, cGMP
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