Our goal is to redefine IT staffing by embracing diversity and inclusion, connecting clients with exceptional and skilled professionals who bring innovative solutions while fostering an environment where every individual feels valued and empowered to thrive.
Senior Quality Engineer
Type: Contract, W2 only
Duration: 12+ months with possible extension
Location: onsite in Hillsboro, OR
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