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Senior CQV Engineer
1 month ago
- Engineer will be responsible for the qualification of an ESCO isolator system.
- Responsible for the creation and execution of validation protocols.
- Responsible for reviewing existing documentation and determining necessary additional testing per Annex 1 requirements.
- Secondary support of feasibility studies.
- Designing validation plans.
- Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
- Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.
- Must be willing to work onsite Watertown, MA.
- Demonstrated experience in execution of Smoke Studies.
- Experience of classifying Isolators and defining regulatory requirements and required validation activities.
- Designing and executing engineering studies for critical process parameter definition and verification prior to validation.
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Validation Enigneer
2 weeks ago
Watertown, United States DPS Group Full timeThe CQV Engineer is responsible for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. Support site validation planning by writing and...
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Validation Enigneer
2 weeks ago
Watertown, United States DPS Group TSO Full time**Summary** The CQV Engineer is responsible for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. Support site validation planning by...
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Specialist II, QA Validation
3 weeks ago
Watertown, United States ElevateBio Full timeElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:ElevateBio...
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Specialist II, QA Validation
3 weeks ago
Watertown, United States ElevateBio Full timeElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role:...
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Specialist II, QA Validation
1 week ago
Watertown, United States Vertex Ventures HC Full timeElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role:...
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Senior Product Development Engineer
1 month ago
Watertown, United States Lincoln Search Consultants Inc Full timeSenior Product Development Engineer (80-100K+) We have an exciting opportunity available for a Senior Product Development Engineer with an established Manufacturer near Watertown, NY. Company Overview : •World Leading Products Manufacturer •Strong benefits package including medical, dental, long and short term disability, life insurance, vacation...
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Senior Embedded Software Engineer
3 weeks ago
Watertown, United States Vicarious Surgical Full timeVicarious Surgical is hiring a Senior Embedded Software Engineer to join our team in Waltham, MA. As a Senior Embedded Software Engineer, you will contribute to the development of much of the firmware that runs our robotic device. You will work closely alongside software, controls, and electrical engineers to specify and design solutions to complex...
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Senior Software Engineer
4 days ago
Watertown, United States ZoomInfo Technologies LLC Full timeAt ZoomInfo, we encourage creativity, value innovation, demand teamwork, expect accountability and cherish results. We value your take charge, take initiative, get stuff done attitude and will help you unlock your growth potential. One great choice can change everything. Thrive with us at ZoomInfo. As a Senior Software Engineer on the Product Foundations...
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Senior Quality Engineer
3 days ago
Watertown, United States Oxenham Group Full timeSenior Quality Engineer Waltham, MA Our client is a stable yet rapidly growing medical device organization in the process of launching a new product for a unique intended use. The company is hiring a Sr. Quality Engineer to drive quality activities from conception to commercialization and sustaining activities. The ideal candidate has strong experience in...
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Senior Engineer
3 weeks ago
Watertown, United States Via Separations Full timeVia Separations is a rapidly growing Boston-area startup dedicated to eliminating CO2 emissions from industrial manufacturing processes. At the intersection of engineering, society, and impact, our team is passionate about making a difference and building the technology and organization to do it. We are a fast-paced, interdisciplinary team backed by leading...
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Senior Software Engineer
6 days ago
Watertown, United States Global Technical Talent, an Inc. 5000 Company Full timeDirect Hire Salary 150k to $170k/year Job Responsibilities: Senior Software Engineer designs and develops new GCP cloud-native services using Golang. Write scalable, robust, testable, efficient, and easily maintainable code. Write automated tests and documentation. Maintain and improve existing codebases. Work across teams on common patterns and...
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Senior Structural Engineer On Call
3 weeks ago
Watertown, United States VHB Full timeOverview: ABOUT THE POSITION Senior Structural Engineer | On-call VHB is seeking a Senior Structural Engineer to join our dynamic and growing Structures group. In this position, you would serve in a lead role in the planning, analysis, and design of a diverse portfolio of structural projects across New England. Responsibilities Manages, develops,...
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Senior Systems Engineer
3 weeks ago
Watertown, United States Boston Dynamics Full timeAs a Senior Systems Engineer, you will join a small cross-functional group defining and developing an unprecedented industry-transforming robotic product. You will help develop and promote a new Systems Engineering (SE) approach that spans requirements generation, architectural trade studies, performance attribute engineering, system analysis, simulation,...
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Senior Quality Engineer
1 week ago
Watertown, United States Exergen Corp Full timeExergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible. Our Temporal Scanner is the most efficacious, non-invasive...
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Senior Quality Engineer
5 days ago
Watertown, United States Exergen Corp Full timeExergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.Our Temporal Scanner is the most efficacious, non-invasive...
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Senior Quality Engineer
1 month ago
Watertown, United States Exergen Corporation Full timeExergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.Our Temporal Scanner™ is the most efficacious, non-invasive...
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Senior Reagent Manufacturing Engineer
2 weeks ago
Watertown, United States Vizgen Full timeVizgen, Inc. - Cambridge, MAVizgen is a rapidly growing company developing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's groundbreaking MERFISH spatial transcriptomics technology images RNA molecules with high...
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Senior Firmware Engineer
1 month ago
Watertown, United States WiTricity Full timeWe are seeking a Senior Embedded Firmware Engineer to design, develop, and support system software for embedded control of WiTricity's wireless power systems. Their focus will be on empowering the wireless transfer of grid power to wireless energy using the control of power electronics. Qualified candidates will have a solid understanding of embedded...
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Senior Process Engineer
1 month ago
Watertown, United States Via Separations Full timeVia Separations is a rapidly growing Boston-area startup dedicated to eliminating CO2 emissions from industrial manufacturing processes. At the intersection of engineering, society, and impact, our team is passionate about making a difference and building the technology and organization to do it. We are a fast-paced, interdisciplinary team backed by leading...
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Senior Reagent Manufacturing Engineer
4 weeks ago
Watertown, United States Vizgen Full timeVizgen, Inc. - Cambridge, MA Vizgen is a rapidly growing company developing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's groundbreaking MERFISH spatial transcriptomics technology images RNA molecules with high...