Quality Engineer

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

[email protected]/[email protected]