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Quality Engineer
2 weeks ago
Peterson Hillsboro, United States Full timeIt's your time, make it matter. · At Peterson, we partner with our customers to build the future. For over 85 years, our peoples' work has shaped the communities where we live, where we raise our families, and where we thrive. Peterson's legacy permeates every aspect of our comm ...
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Quality Engineer
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Customer Quality Engineer
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Qorvo Hillsboro, United StatesPress Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Customer Quality Engineer · Job Type: · Full-Time · Location: · OR - Hillsboro, US · Requisition ID: · 7503 · Qorvo (Nasdaq: QRVO) supplies innovative semiconductor solutions that m ...
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Senior Quality Engineer
6 days ago
Genentech Hillsboro, United StatesThe Position · This role is a crucial part of our · Quality Systems and Validation team · , which plays a vital role in ensuring the design, development, and qualification of equipment into GMP manufacturing and laboratory areas, qualification of analytical methods and GMP are ...
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Customer Quality Engineer
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WorkSource Oregon Hillsboro, United StatesLocation field must contain 'city, state' or a zip code to perform a radius search (e.g., · Denver, CO · or · City and state must be separated by a comma followed by a space (e.g., · Houston, TX ) · WorkSource Oregon · Customer Quality Engineer · in · Hillsboro , · Oregon ...
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Materials Quality Engineer
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Materials Quality Engineer
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Materials Quality Engineer
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Sr Quality Engineering Manager
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Sr Quality Engineering Manager
1 week ago
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Sr Quality Engineering Manager
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Sr Quality Engineering Manager
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Sr Quality Engineering Manager
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Sr Quality Engineering Manager
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5099 Quality Engineer ll
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Harvest Technical Services Hillsboro, United StatesJob DescriptionJob Description · *Onsite in Hillsboro, OR · 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 ...
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Principal Quality Validation Engineer
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Genentech Hillsboro, United StatesThe Position · At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every ...
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Server Platform Quality and Reliability Engineer
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Server Platform Quality and Reliability Engineer
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Customer Support Technician I
1 week ago
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Radiant Ventures Hillsboro, United StatesCompany Description · Continental develops groundbreaking technologies and services for sustainable and connected mobility of people and goods. The technology company, founded in 1871, offers safe, efficient, intelligent, and affordable solutions for vehicles, machinery, traffic, ...
Senior Quality Engineer - Hillsboro, United States - Genentech
Description
The PositionAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action, we believe that good business means a better world.
This role is a crucial part of our Quality Systems and Validation team
, which plays a vital role in ensuring the design, development, and qualification of equipment into GMP manufacturing and laboratory areas, analytical methods and GMP areas. As a member of this team, you will have the opportunity to work closely with various functions, drive continuous improvement, and provide oversight to ensure compliance with current GMP requirements. Your collaboration with site and corporate level functions will contribute to the resolution of quality issues and the implementation of best practices. Join our team and be a part of ensuring our equipment, systems and areas are always inspection ready.
The Opportunity:
As a
SeniorQuality Engineer
, your main accountability will be to provide quality oversight to projects focused on the design, development, and qualification of equipment into GMP manufacturing and laboratory areas. In this role, you will ensure compliance with current GMP requirements, troubleshoot and resolve quality issues, and drive continuous improvement initiatives.
Additionally, you will:
Provide quality oversight for site qualification and validation activities, including Computer System Validation
Review and approve qualification documents for cGMP and technical content
Provide technical and quality qualification assessment and approval for engineering and process changes.
Collaborate with departments to ensure compliant and efficient execution of qualification activities
Present and provide rationale for the qualification program during audits and regulatory inspections
Provide input into investigations with qualification impact and collaborate on validation standards and procedures
Who You Are:
You possess a Bachelor's degree in engineering or life sciences with at least 6 years of qualification experience in the pharmaceutical or biotechnology industry
You possess a strong working knowledge of qualification engineering principles and concepts applicable to process, system performance, and regulatory requirements
You are familiar with Risk Assessment Methodology (PHA, FMEA, FTA) and have strong knowledge of EU and US cGMPs and applicable validation guidance
You have demonstrated experience working in a matrixed environment to achieve milestones and goals
Preferred:
Laboratory design and start-up experience
Experience in the design, build, and deploy phases for both automation and execution systems (Delta V/SCADA, Syncade, MES, BAS, EBR, Pi Data historian, etc.) in a regulated pharmaceutical manufacturing environment
Relocation is not approved for this position.
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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us.
Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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