Senior Staff Product Validation Engineer
2 weeks ago
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Join us as we expand our business and quality department, which is passionate about revolutionizing the way things are done in our industry We are seeking a highly skilled and experienced Senior Product Validation Engineer to join our team. The successful candidate will play a meaningful role in ensuring our products' quality, reliability, and compliance through meticulous validation and testing processes. This is an excellent opportunity for a professional with a strong background in product validation, particularly within the bioprocessing or biopharma industry. Join us in creating exceptional and functional experiences. What will you do? Develop and implement comprehensive validation plans, protocols, and reports for Bioprocess systems. Lead product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Coordinate and carry out validation testing according to regulatory requirements and industry standards. Perform risk assessments and develop mitigation strategies to address potential product validation issues. Analyze validation data to identify trends, discrepancies, and areas for improvement. Prepare detailed validation reports and present findings to multi-functional teams and management. Collaborate with R&D, manufacturing, quality, and other departments to ensure seamless integration of validation activities. Manage and maintain accurate and organized validation documentation and records. Ensure all validation activities are detailed in compliance with regulatory and company requirements. How will you get here? Education: Bachelor of Science degree in Engineering or Science field and 3+ years of validation experience in the Bioprocessing industry or equivalent validation cGMP experience. Experience: Minimum of 3 years of product or process validation, Manufacturing or Quality Engineering or equivalent role. Strong understanding of validation principles, methodologies, and regulatory requirements. Strong background in completing validation protocols for complex systems. Extensive experience in solving coordinated systems and resolving technical issues independently. Advanced knowledge of Bioprocessing equipment architecture, network infrastructure, and process control solutions such as DeltaV DSC or PLCs is a plus. Proficiency in data analysis and statistical tools. Familiarity with bioprocessing equipment and systems. Detailed, with a focus on maintaining high standards of quality and compliance. Certification in relevant areas (e.g., Lean, Six Sigma, Project Management) is a plus. Knowledge, Skills, Abilities: Proven ability to effectively communicate with customers and internal partners to achieve a great outcome for everyone. Understand electrical and mechanical assembly drawings is a must. Attention to detail for documentation completion. Familiarity with Agile PLM, ERP Systems, JIRA, Trackwise Systems. Familiarity with Emerson DeltaV Automation and Control Platform or similar advanced process control systems is a plus. Must be able to multitask and respond to shifting priorities. Must be dedicated to achieving desired outcomes. Must have prior mechanical and process equipment experience. Technical or Engineering background with strong analytical and interpersonal skills. Able to travel occasionally (
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Sr. Product Validation Engineer
3 weeks ago
Santa Clara, United States SiTime Corporation Full timeJob DescriptionJob DescriptionAbout SiTime SiTime Corporation is the precision timing company. Our semiconductor MEMS programmable solutions offer a rich feature set that enables customers to differentiate their products with higher performance, smaller size, lower power and better reliability. With more than 3 billion devices shipped, SiTime is changing the...
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Product Validation Engineer
5 days ago
Santa Clara, California, United States SiTime Corporation Full timeCompany OverviewSiTime Corporation is a leading provider of precision timing solutions. Our semiconductor MEMS-based devices offer a rich feature set that enables customers to differentiate their products with higher performance, smaller size, lower power, and better reliability.Estimated Salary$120,000 - $180,000 per year, depending on experience.Job...
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Sr. Product Validation Engineer
3 weeks ago
Santa Clara, United States SiTime Corporation Full timeJob DescriptionJob DescriptionAbout SiTime SiTime Corporation (NASDAQ: SITM) is the precision timing company. Our semiconductor MEMS programmable solutions offer a rich feature set that enables customers to differentiate their products with higher performance, smaller size, lower power and better reliability. With more than 3 billion devices shipped, SiTime...
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Product Validation Engineer
2 weeks ago
Santa Clara, United States SiTime Full timeAbout SiTime SiTime Corporation is the precision timing company. Our semiconductor MEMS programmable solutions offer a rich feature set that enables customers to differentiate their products with higher performance, smaller size, lower power and better reliability. With more than 3 billion devices shipped, SiTime is changing the timing industry. For more...
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Process Validation Engineer
2 months ago
santa clara, United States GForce Life Sciences Full timeConsultant, Manufacturing/Process Validation Engineer, Medical DeviceOur client, a Cardiovascular start up, has engaged GForce Life Sciences to provide a manufacturing/process validation engineer. This position will report to a Sr Quality Director. This individual will be responsible for (XYZ). This position requires the ability to do Support the clients...
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Senior Principal System Validation Engineer
2 weeks ago
Santa Clara, California, United States Tbwa ChiatDay Inc Full timeJob Overview:Astera Labs is a global leader in innovative connectivity solutions, unlocking the full potential of AI and cloud infrastructure.We are seeking an experienced Data Center Validation Expert to join our team. The successful candidate will be responsible for developing and performing system validation tests using leading-edge data center equipment...
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Senior Product Design Engineer
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Santa Clara, United States Goertek Electronics Full timeSummaryWe are seeking a Senior Product Design Engineer / Product Design Manager at GoerTek Santa Clara office to work on consumer electronics optical products. The position works closely with customers engineering team on product development from concept to mass production. Internally work and drive with cross functional team to meet product specification...
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Senior Product Design Engineer
1 month ago
santa clara, United States Goertek Electronics Full timeSummaryWe are seeking a Senior Product Design Engineer / Product Design Manager at GoerTek Santa Clara office to work on consumer electronics optical products. The position works closely with customers engineering team on product development from concept to mass production. Internally work and drive with cross functional team to meet product specification...
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Senior Product Design Engineer
1 month ago
santa clara, United States Goertek Electronics Full timeSummaryWe are seeking a Senior Product Design Engineer / Product Design Manager at GoerTek Santa Clara office to work on consumer electronics optical products. The position works closely with customers engineering team on product development from concept to mass production. Internally work and drive with cross functional team to meet product specification...
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Santa Clara, United States Tbwa ChiatDay Inc Full timeSenior Principal System Validation EngineerAstera Labs is a global leader in purpose-built connectivity solutions that unlock the full potential of AI and cloud infrastructure. Our Intelligent Connectivity Platform integrates PCIe, CXL, and Ethernet semiconductor-based solutions and the COSMOS software suite of system management and optimization tools to...
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Senior Quality Engineer
1 month ago
santa clara, United States Cypress HCM Full timeA medical device manufacturing client is looking to hire a new senior quality engineer for their catheter division of business! This Sr. Catheter Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality...
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Senior Quality Engineer
1 month ago
santa clara, United States Cypress HCM Full timeA medical device manufacturing client is looking to hire a new senior quality engineer for their catheter division of business! This Sr. Catheter Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality...
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Senior Quality Engineer
1 month ago
Santa Clara, United States Cypress HCM Full timeA medical device manufacturing client is looking to hire a new senior quality engineer for their catheter division of business! This Sr. Catheter Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality...
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Staff Software Engineer
4 days ago
Santa Clara, United States Eightfold LLC Full timeAbout Eightfold Eightfold is rapidly growing and revolutionizing talent management with AI. We are seeking exceptional engineers to join our team and help us build the next generation of our AI-powered talent platform. About the Job As the most senior-level Staff Software Engineer on this product dev team, you will own major roadmap items for our...
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Senior Principal System Validation Engineer
1 month ago
santa clara, United States Huntech USA LLC Full timeDevelop and perform system validation tests using leading-edge Data Center equipment and scalable automation platforms. The validation team holds customers’ system requirements in the highest regard and is solely responsible for certifying a product’s conformance to this high bar.Understand the performance and functionality requirements ICs must deliver...
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Senior Principal System Validation Engineer
4 weeks ago
santa clara, United States Huntech USA LLC Full timeDevelop and perform system validation tests using leading-edge Data Center equipment and scalable automation platforms. The validation team holds customers’ system requirements in the highest regard and is solely responsible for certifying a product’s conformance to this high bar.Understand the performance and functionality requirements ICs must deliver...
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Senior Principal System Validation Engineer
1 month ago
Santa Clara, United States Huntech USA LLC Full timeDevelop and perform system validation tests using leading-edge Data Center equipment and scalable automation platforms. The validation team holds customers’ system requirements in the highest regard and is solely responsible for certifying a product’s conformance to this high bar.Understand the performance and functionality requirements ICs must deliver...
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Cloud Intelligence Senior Staff Engineer
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Santa Clara, California, United States Palo Alto Networks Full timeJob Title: Senior Cloud Intelligence SQA EngineerAt Palo Alto Networks, we're changing the game in cybersecurity. We're not just a company - we're a mission-driven team dedicated to protecting our digital way of life.### Responsibilities- Conduct functional testing of our cloud intelligence offering with a focus on Logging and Reporting- Develop and execute...
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Santa Clara, California, United States Menlo Ventures Full timeAbout the RoleWe are seeking an experienced Senior Software Engineer II to join our team at Carta. In this role, you will have the opportunity to work on complex SaaS products with Service Oriented Architecture (SOA) and microservices.As a Senior Software Engineer II, you will be responsible for defining requirements and building solutions for products that...
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Process Validation Engineer
1 month ago
Santa Clara, CA, United States GForce Life Sciences Full timeConsultant, Manufacturing/Process Validation Engineer, Medical DeviceOur client, a Cardiovascular start up, has engaged GForce Life Sciences to provide a manufacturing/process validation engineer. This position will report to a Sr Quality Director. This individual will be responsible for (XYZ). This position requires the ability to do Support the clients...
