Hillsboro, Oregon, United States · Hybrid
$163k–$222k/yr
The Position Genentech, Inc. seeks a Principal Validation Engineer at its Hillsboro, OR location. Duties: Author, review, & approve validation master plans, validation & change control documentation including protocols, …
Skills: Validation engineering, Sterilization, Aseptic filling, Risk assessment, Root cause analysis
Hillsboro, Oregon, United States · Hybrid
The group you’ll be a part of The Customer Support Business Group focuses on enabling our customers with premier customer support throughout their lifecycle with Lam. We drive performance, productivity, safety, and quali…
Skills: Field service management, Technical support coordination, Preventive maintenance, Equipment installation, Engineering change upgrades
Hillsboro, Oregon, United States · On-site
$26/hr–$39/hr
Who We Are At nLIGHT, we are constantly on the cutting-edge of laser technology in a massively growing market. We are a leading provider of high-power semiconductors and fiber lasers for industrial, microfabrication, and…
Skills: Production Planning, Purchasing, Supply Chain Management, ERP, MRP
Hillsboro, Oregon, United States · On-site
Join Davis Tool's expanding Maintenance Team and make a difference. Our Maintenance Mechanic’s repair equipment, perform preventive and predictive maintenance for both the manufacturing departments and building facilitie…
Skills: Preventive maintenance, Predictive maintenance, Troubleshooting, Mechanical systems, Hydraulic systems
Hillsboro, Oregon, United States · On-site
$102k–$173k/yr
Company Overview KLA is a global leader in diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic device in the world is produced using our technologies. No laptop, smartphone, …
Skills: Optical metrology, Thin film characterization, Semiconductor process integration, Ellipsometry, Reflectometry
Hillsboro, Oregon, United States · On-site
$142k–$200k/yr
Job Details: Job Description: Embark with us on a journey of growth and transformation as we create exceptionally engineered technology and bring AI everywhere. As a valued team member, your adaptability and attention to…
Skills: Electrical Measurements, Circuit Analysis, Device Design, Characterization, Instrumentation
Hillsboro, Oregon, United States · On-site
The group you’ll be a part of The Customer Support Business Group focuses on enabling our customers with premier customer support throughout their lifecycle with Lam. We drive performance, productivity, safety, and quali…
Skills: Semiconductor equipment maintenance, Troubleshooting, Diagnostics, Electrical schematics, Mechanical schematics
Phoenix, Arizona, United States · Hybrid
$191k–$270k/yr
Job Details: Job Description: The Role and Impact As a PCB Technologist at Intel, you will play a pivotal role in shaping the future of Intel's most demanding platforms, ranging from AI, Datacenter to Client Graphics, wi…
Skills: PCB fabrication, Signal integrity, Supplier quality management, Data analysis, Benchmarking
Chandler, Arizona, United States · On-site
$27/hr–$46/hr
Company Overview KLA is a global leader in diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic device in the world is produced using our technologies. No laptop, smartphone, …
Skills: Electronics, Optics, Mechanical Systems, Electro-mechanical Systems, Electro-optical Systems
QUANTUM GLOBAL TECHNOLOGIES, LLCHillsboro, Oregon, United States · On-site
Join UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car, and device that uses artificial intelligence. This is a critical t…
Skills: Account management, Sales, Customer relationship management, Technical sales, CRM systems
Hillsboro, Oregon, United States · On-site
$22/hr–$25/hr
Responsibilities: Under direct and general supervision, this individual is responsible for the operation (basic features) of automated equipment used for the assembly and soldering of printed circuit board assemblies (PC…
Skills: Machine operation, Soldering, PCBA assembly, Equipment maintenance, Quality control
Hillsboro, Oregon, United States · On-site
Description Location: Hillsboro, Oregon (On Site) StenTech's Pentagon location in Hillsboro, Oregon is seeking a highly skilled and motivated Senior CAM Programmer to join our manufacturing team. This position is ideal f…
Skills: CAM Programming, CNC Machining, GibbsCAM, 3, 4, and 5-Axis Machining, GD&T
Hillsboro, Oregon, United States · On-site
$70k–$75k/yr
Overview Imagine engineering the sophisticated fluid, gas, and chemical delivery systems that form the lifeblood of the world's most advanced semiconductor fabrication facilities. At SSOE you will continuously expand you…
Skills: Process engineering, Fluid transfer, Heat exchange, High-purity piping, Ultrapure water systems
Hillsboro, Oregon, United States · On-site
Classification: Non-Exempt Reports to: Service Center Manager Date of Creation: June 9, 2022 JOB DESCRIPTION (Summary/Objective) The Service Center Coordinator will support the service center team by providing administra…
Skills: Administrative support, Quote preparation, Invoice processing, Customer communication, SOP development
Hillsboro, Oregon, United States · Hybrid
The group you’ll be a part of The Customer Support Business Group focuses on enabling our customers with premier customer support throughout their lifecycle with Lam. We drive performance, productivity, safety, and quali…
Skills: Account management, Customer relationship management, Strategic planning, Business acumen, Negotiation
Hillsboro, Oregon, United States · On-site
Job Description California applicants: Please click here to review the Costco Applicant Privacy Notice. The jobs listed are examples of the typical kinds of positions that Costco may hire for when openings exist. The lis…
Skills: Meat wrapping, Labeling, Equipment sanitation, Product rotation, Meat grinding
Hillsboro, Oregon, United States · Hybrid
$144k–$171k/yr
Job Details: Job Description: Join Intel as a Module Engineer, where you will play a pivotal role in driving innovation and advancing Intel's manufacturing capabilities from component feasibility through high-volume prod…
Skills: Manufacturing Process Optimization, Feasibility Studies, Theoretical Simulations, Test Program Validation, Root Cause Analysis
Hillsboro, Oregon, United States · Hybrid
$149k–$200k/yr
Job Details: Job Description: Join Intel as a Silicon Product Engineer, where you will play a pivotal role in ensuring the quality, reliability, and manufacturability of Intel's cutting-edge silicon products and technolo…
Skills: Silicon Product Engineering, Failure Analysis, Yield Optimization, Test Methodology Development, Circuit Characterization
Hillsboro, Oregon, United States · Hybrid
$128k–$157k/yr
Job Details: Job Description: Join Intel as a System Software Engineer, where you will play a pivotal role in designing, developing, and optimizing software solutions across Intel's cutting-edge technology portfolio. In …
Skills: System Software Design, Firmware Development, Driver Development, Operating Systems, Middleware
Hillsboro, Oregon, United States · Hybrid
$140k–$171k/yr
Job Details: Job Description: Join Intel's dynamic team as a Manufacturing Engineer, where you will play a pivotal role in driving innovation, efficiency, and excellence across Intel's advanced manufacturing operations. …
Skills: Manufacturing Process Development, High-Volume Manufacturing, Cross-functional Collaboration, Process Optimization, Technical Troubleshooting
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The Principal Validation Engineer will oversee validation master plans, sterilization processes, and technical assessments for drug product manufacturing. They will also lead cross-functional teams in root cause analysis, regulatory audits, and the implementation of new process technologies.
Candidates must hold a Master's degree with 8 years of experience or a Bachelor's degree with 10 years of experience in Pharmaceutical or Chemical Engineering. Required expertise includes sterilization techniques, aseptic operations, clean room technologies, and proficiency with quality systems like Trackwise and Veeva.
Genentech, Inc. seeks a Principal Validation Engineer at its Hillsboro, OR location.
Duties: Author, review, & approve validation master plans, validation & change control documentation including protocols, summary reports etc., for development and validation activities. Provide technical and engineering expertise to support the drug product manufacturing process, as well as process/product tech transfers and/or new technologies introductory projects. Serve as Site Sterilization Subject Matter Expert (SME); develop and manage sterilization processes including overseeing change management, technical assessments, protocol/summary reports and field executions. Implement sterilizations strategies for aseptic filling lines along with Risk Assessments to ensure compliance with the current global regulatory standards. Coordinate, Manage, and Perform Initial and continuous process qualifications. Participate in the identification, evaluation, and implementation of new process technologies in alignment with business objectives and regulatory requirements. Own and facilitate planned and unplanned events, and Root Cause Analysis along with serving as a risk management representative on cross-functional and multi-site teams. Conduct investigations and atypical events, as well as resulting corrective or preventive action implementation. Minimize potential contamination to product by identifying gaps and improving existing site contamination control procedures. Improve filling line down time through change management and technical and risk assessments, and through continuous improvement processes. Improve technical skill for junior engineers and contractors on validation principles and equipment functionality to increase overall productivity, performance and to develop new SMEs. Participate in FDA and global regulatory audits and pre-approval inspection. Serve as audit lead and represent and defend Validation/Engineering requests, and respond to 483 form queries and concerns. May telecommute up to 1 day per week.
Education and experience required: Master’s degree, or foreign equivalent, in Pharmaceutical or Chemical Engineering or related field and 8 years of experience as a Validation Engineer or related position
Alternative education and experience required: Bachelor’s degree, or foreign equivalent, in Pharmaceutical or Chemical Engineering or related field and 10 years of progressive, post-baccalaureate experience as a Validation Engineer or related position
Special Requirements: 5 years of experience must include:
Sterilization using steam, dry heat and Chemical decontamination
Aseptic facility and drug product manufacturing operations
Clean room technologies (ISO grade A, B and interventions) including media fill and air flow visualization needed to support sterile manufacturing process
Equipment Qualification with family/grouping approaches
Sterile Boundary including product path and sterile hold times
Proven technical leadership capabilities and structured problem solving (Root Cause Analysis)
Experience with Quality systems including Trackwise, Veeva, and ValGenesis
#LI-DNI #DNI #DE-DNI
The expected annual salary range for this position based on the primary location for this position of Oregon is $162,750 to $222,480 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Worksite: 4625 NE Brookwood Pkwy., Bldg. 11, Hillsboro, OR 97124
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
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