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Validation Engineer
1 week ago
Thermo Fisher Scientific Union, United StatesAs part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cl Validation Engineer, Validatio ...
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Validation Engineer
1 week ago
Thermo Fisher Scientific Union, United StatesJob Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...
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Equipment Validation Engineer
1 week ago
Tata Consultancy Services Union, United States· •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industryGoodProject Management experience · ...
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Equipment Validation Engineer
1 week ago
Tata Consultancy Services Union, United States· •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industryGoodProject Management experience · ...
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Validation Engineer
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Thermo Fisher Scientific Cincinnati, United StatesJob Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and s ...
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Lead Validation Engineer
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Fowler Placement Services Cincinnati, United StatesLocation · Cincinnati, OH · **Responsibilities:** · The holder of this position is charged with leading validation effort to prove control of the critical aspects of company operations, related to process, cleaning, or other elements. · * Serve as a subject matter expert in proc ...
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Equipment Validation Engineer
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Tata Consultancy Services Cincinnati, United States· •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industry · GoodProject Management experien ...
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Equipment Validation Engineer
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Tata Consultancy Services Cincinnati, United States· •Understandingof medical device regulations and standards · •ProjectManager with Strong process validation, process controls, process specificationand risk analysis experience · •Experiencein working in a medical device manufacturing industry · GoodProject Management experien ...
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Computer System Validation Engineer
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Computer System Validation Engineer
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Aprecia Pharmaceuticals Blue Ash, United StatesGeneral Purpose of Position · : · This position performs and leads computer system validation (CSV) projects including developing, authoring, and executing CSV documentation and SOPs according to ISPE GAMP 5 Validation Life Cycle. The position is responsible for the execution, ...
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Validation Engineer, Packaging Equipment
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Katalyst Healthcares and Life Sciences Cincinnati, United Stateshis position will provide planning and implementation support for the Akamai Global Communications team, including external and internal communications, industry analyst relations, and reputation management, with a focus on improving systems and processes. The Senior Specialist w ...
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Team Leader
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Infinity Systems Crescent Springs, United StatesEvery day, people around the world use transportation that has been developed, tested, and validated with dSPACE solutions. They can trust that their vehicle's drive is energy-efficient, that intelligent assistance systems make driving more comfortable, and that the plane they ar ...
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Skyline Enterprises Fort Wright, United StatesWho we are: Working together, growing together, creating new things together: EDAG connects people and the future - here, companies and employees share the same vision. With us, you can pursue your own career path at a high level, nationally or internationally. · In Vehicle Engin ...
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Phoenix Industries Delhi Hills, United StatesYour Responsibilities · Development and optimization of mechanical system components · Participation in the determination of control concepts for PLC programming · Design and project planning of fossil heating systems for glass melting furnaces · Technical specification of system ...
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Diesel Technician/Mechanic III
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Traffic Engineer
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Talent Search PRO Union, United StatesJob Description:We are currently seeking a proven professional to work on various projects within our Transportation Market. The Senior Project Engineer/Traffic Engineer will have demonstrated leadership and technical experience in Ohio Department of Transportation (ODOT) and mun ...
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Traffic Engineer
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Talent Search PRO Union, United StatesJob Description: · We are currently seeking a proven professional to work on various projects within our Transportation Market. The Senior Project Engineer/Traffic Engineer will have demonstrated leadership and technical experience in Ohio Department of Transportation (ODOT) and ...
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Concrete Field Engineer
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Design Engineer
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Crane Co. Union, United StatesPosition Summary: · Plan, execute, and functionally support customer design and development projects. Owns impactful projects and processes to the business that are complex, multi-dimensional, and drive improvements to the wide product portfolio. Works with cross functional teams ...
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Business Analyst
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RIT Solutions, Inc. Union, United StatesMust be based in EST Must have a valid LinkedIn profile 9+ years of experience requiredMust have a strong insurance backgroundProject Description Workflow automation of non-technical invoices Task Description Business analysis, Requirements engineering, Process refinement Require ...
Lead Validation Engineer - Union, United States - Ssgnetwork
Description
Location Cincinnati, OH
**Responsibilities:**
The holder of this position is charged with leading validation effort to prove control of the critical aspects of company operations, related to process, cleaning, or other elements.
Serve as a subject matter expert in process and cleaning validation.
Support validation and requalification activities for process and cleaning including work in manufacturing area for collection of samples, cleaning surface sampling, visual inspection, etc.
Author, review, and approve validation documents for systems/projects of varying complexity from approved templates in accordance with approved Standard Operating Procedures. Review change controls and assess their impact as well as define the required validation activities.
Understand the science and areas of technical knowledge that underpin area of focus & must be able to apply this knowledge in the development of validation approach and in the presentation, documentation & review of outcome.
Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed equipment, process, equipment, facility or procedure.
Assist other areas of the department as needed by applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery.
Work on cross-functional teams with peers from other technical areas to discuss issues, to develop scientific understanding, and to determine solutions. Communicate proactively with team members, stakeholders, and management regarding progress, issues, and plans for resolution and to ensure the project team and/or network is fully informed of updates and improvements.
Determine levels of importance or risk to be assigned to elements under review using scientific rationale to justify scale of effort.
Understand best industry practice, current developments and opportunities arising for company
Ensure Validation systems (policies, procedures, reviews, VMPs, etc.) meet current / changing industry demands and that they do so effectively; the holder of this position is also responsible for the maintenance of these validation systems and ensuring compliance of Validation corrective actions.
**Academic/Technical Qualifications:**
Bachelors Degree in a Science or Engineering discipline required
5-8+ years relevant validation experience required
Familiarity with Regulatory requirements and guidance applicable in area(s) of deployment preferred
Experience working with OSD products preferred
Must be able to travel up to 10%