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 sites 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:
Bachelors degree in Engineering Life Sciences or related field.
510 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
/
Required Skills:
Validation cGMP
Required Education:
Bachelors
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 Engi...
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 sites 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:
Bachelors degree in Engineering Life Sciences or related field.
510 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
/
Required Skills:
Validation cGMP
Required Education:
Bachelors
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