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.
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.
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
If interested, please send us your updated
resume at
[email protected]/[email protected]
Skills Required
- Bachelor's degree in Engineering, Life Sciences, or related field
- 5-10 years' experience in 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
- Experience with Qualification & Validation (Equipment, Process, Cleaning, CSV)
- Experience with Quality Systems and cGMP compliance
- Experience in Risk Assessment, Change Control, and Deviation Management
- Excellent analytical, problem-solving, and communication skills
- Ability to work effectively across functions and adapt to changing priorities
What We Do
Dawar Consulting Inc. is a professional services and staff augmentation firm specializing in IT consulting, workforce solutions, and HCM/HRIS services. They provide technology and business consulting, project delivery, and IT support to help clients achieve their strategic goals. With expertise across IT, Engineering, and Finance, they deliver best-in-class workforce solutions and innovative strategies to drive operational efficiency and business success.
