Quality Engineer II - Tailored Management

This is an excellent opportunity to start a career with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients' lives! 
Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124
Shift: 8 AM to 5 PM Monday to Friday

Main Purpose of the Position:

• Provide technical review and approve validation deliverables ensuring proper study design and execution.
• Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
• Working with multiple functions, lead solution of validation issues following cGMP regulaJotions and  standards.
• Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design and regulatory requirements.
• Provide Quality Assurance oversight to Validation, Revalidation and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.
• Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
• Provide technical review and approve validation deliverables ensuring proper study design and execution.
• Maintain the compliance status of the assigned validation areas at a state of inspection readiness.

Job Duties/Responsibilities:

• Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.
• Support the validation program during regulatory agency inspections.
• Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Be accountable for behaviors as described in ompetencies.
• Provide input into the design and presentation of validation performance metrics.
• Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones and schedules.

Technical Duties/Responsibilities:

• Provide Quality oversight (including technical requirements and regulatory expectations) of site validation efforts.
• Review and approve validation documents (e.g. Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.
• Provide technical guidance for study design including sampling plans, acceptance criteria and rationale.
• Provide technical and quality validation assessment and approval for engineering and process changes.
• Collaborate with departments to ensure validation activities are executed compliantly, with efficiency and effectiveness.
• Review, assess and approve Quality Risk management documents.
• Participate in the risk stages of procuring new equipment.
• Collaborate with departments to ensure risk management and validation activities are executed efficiently and effectively.
• Review and approve Alarm Review documentation.
• Provide input into investigations with potential validation impact.
• Provide input and collaborate with other site/functional units and Corporate on validation standards and procedures.

Qualifications / Requirements:

• B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
• Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency and  requirements.
• Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), preferred.
• Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
• Basic knowledge of EU and US CGMPs and applicable validation guidance.
• Ability to make sound decisions about quality and technical subjects.
• Ability to communicate clearly and professionally both in writing and verbally.