Senior Quality Engineer

Senior Quality Engineer

Type: Contract, W2 only

Duration: 12+ months with possible extension

Location: Hillsboro, OR, USA

Pay: $54/hr-$64/hr, DOE

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

A global biotechnology leader is seeking a Senior Quality Engineer to support a drug product & finished goods manufacturing organization responsible for the reliable delivery of the companys commercial portfolio & pipeline products.

Responsibilities:

• 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.
• 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.

Knowledge, Skills and Abilities:

• Bachelor's degree with 5-10 years of industry experience or equivalent qualifications.
• Biopharma/pharma industry experience in technical validation or quality validation, and strong technical knowledge of qualification and validation principles.
• Ability to interpret and relate quality standards for implementation and review.
• Sound knowledge of cGMPs or equivalent regulations.

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs