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Senior Quality Engineer

4 weeks ago

Oregon, United States R&D Partners Full time

Overview R&D Partners is seeking to hire a Senior Quality Engineer in Hillsboro, OR. Responsibilities Provide quality oversight for the site qualification/validation program, applying knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards. Perform quality oversight of qualification and validation activities for equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods. Guide internal customers on best practices to execute consistent, reproducible, and compliant qualification and validation activities. Assess and approve changes that impact the validated state and/or require qualification/validation. Review and approve documents to support qualification and validation activities, ensuring compliance with internal quality system requirements. Qualifications Bachelors degree with 5-10 years of industry experience or equivalent qualifications. Biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation, with 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. Knowledge of cGMPs or equivalent regulations. Benefits Medical insurance PPO, HMO & 401k plan Employee Assistance Program Long-term disability Weekly payroll Online timecard approval Pay Scale $55,556 - $131,863 (Dependent on Experience) About R&D Partners R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Related Jobs System Engineer Tucson Metro Area, AZ Engineering Systems Specialist Tucson Metro Area, AZ System Support Engineer California All, CA #J-18808-Ljbffr