Title: Senior Quality Engineer, Req : ROCGJP
Location: Hillsboro, OR (100% onsite, No remote, No hybrid)
Duration: 15 months Contract
Job Description:
Education and Experience:
- A Bachelor's degree with 8 years of industry experience or a Master's degree with 5 plus years.
- Biopharmaceutical or pharmaceutical 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.
- Ability to make sound decisions about quality and technical subjects.
- Sound knowledge of cGMPs or equivalent regulations.
- Flexibility in problem solving and work hours to meet business objectives.
- Able to quickly and consistently establish rapport and collaborate effectively with team members and partners.
Responsibilities:
- You will provide guidance to internal customers on best practices for executing consistent, reproducible, and compliant qualification and validation activities.
- You will provide assessment and approval for changes that impact the validated state and/or require qualification/validation.
- You will review and approve a variety of documents to support qualification and validation activities, ensuring compliance with internal quality system requirements.
- You will provide input and quality oversight to qualification/validation exceptions/deviations.
- You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
- You will exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.