Senior Quality Engineer

Job Title: Senior Quality Engineer
Job Location: Hillsboro, OR
Job Duration: 12-13 Months (possibility of extension)

Role Summary:

• In this exciting role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards to provide quality oversight for the site qualification/validation program.

Key Responsibilities:

• Perform quality oversight of qualification and validation activities associated with equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.
• Provide guidance to internal customers on best practices for executing consistent, reproducible, and compliant qualification and validation activities.
• Provide assessment and approval for changes that impact the validated state and/or require qualification/validation.
• Review and approve a variety of documents to support qualification and validation activities, ensuring compliance with internal quality system requirements.
• Provide input and quality oversight to qualification/validation exceptions/deviations.
• Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
• Exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.

Qualifications:

• You hold a Bachelor’s degree with 5-10 years industry experience or equivalent qualifications.
• You have biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation, and strong technical knowledge of qualification and validation principles.
• You have an ability to interpret and relate quality standards for implementation and review.
• You have the ability to make sound decisions about quality and technical subjects.
• You exhibit sound knowledge of cGMPs or equivalent regulations.
• You have flexibility in problem solving and work hours to meet business objectives.
• You are able to quickly and consistently establish rapport and collaborate effectively with team members and partners.