Our client, a world leader in diagnostics
and life sciences, is looking for a<\/span><\/span> "<\/span><\/span><\/b><\/span> <\/span><\/span><\/span>Quality Engineer” based out of Hillsboro,
OR.<\/span><\/span><\/span><\/b>
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Job Duration:<\/span><\/span><\/span><\/b> <\/span><\/span>Long term Contract (Possibility Of
Further Extension)<\/span><\/span><\/b><\/span>
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Pay Rate: $65/hr on W2<\/span><\/span><\/span><\/b>
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Company Benefits: Medical, Dental,
Vision, Paid Sick leave, 401K<\/span><\/span><\/span><\/b>
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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.
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Provide quality oversight of qualification and validation activities for equipment, facilities, utilities, manufacturing processes, cleaning, sterilization, analytical methods, and computerized systems.
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Review, assess, and approve validation and qualification documentation, including protocols, reports, and change controls.
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Evaluate and approve changes impacting validated state and participate in deviation assessments.
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Ensure adherence to internal quality system requirements and regulatory expectations.
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Collaborate cross -functionally to drive compliant, consistent, and efficient validation practices.
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Apply sound technical judgment in resolving complex quality and validation issues.
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Bachelor’s degree in Engineering, Life Sciences, or related field.
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5–10 years of experience in the biopharmaceutical or pharmaceutical industry with focus on validation or quality assurance.
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Strong knowledge of qualification/validation principles and lifecycle approach.
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In -depth understanding of cGMPs and health authority expectations.
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Excellent analytical, problem -solving, and communication skills.
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Ability to work effectively across functions and adapt to changing priorities.
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Qualification & Validation (Equipment, Process, Cleaning, CSV)
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cGMP Compliance & Quality Systems
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Risk Assessment, Change Control, and Deviation Management
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If interested, please send us your updated
resume at<\/span><\/span><\/span>
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hr@dawarconsulting.com
kavitha@dawarconsulting.com