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Process validation Engineer

Company: Dew Software
Location: San Jose
Posted on: October 18, 2020

Job Description:

If interested, submit your updated resume in WORD(.doc) format with following details Full Name Current Location Expected Hourly rateSalary Work Authorization POSITION DESCRIPTION Provide engineering leadership for engineering design, equipment development, assembly methods, process validation and software development of products. Project management responsibilities include the coordination and completion of projects on time within budget and within scope. Oversee all aspects of projects. Set deadlines, assign responsibilities and monitor and summarize progress of project. Prepare reports for upper management regarding status of project. POSITION RESPONSIBILITIES Participate on projects to develop assembly methods, tooling, equipment and processes for products with emphasis on following quality systems and rigorous documentation to help companies with regulatory non-compliance issues. Partner with a Global team lead to collaborate and execute the project with an onshoreoff-shore model. Developing Validation plan and Validation summary report, review relevant documents like test plan, requirement traceability matrix, IQ, OQ, PQ, URS, Initial Risk Assessment, Test Method Validation, FAT, SAT etc. Provide input in planning for projects, write technical computer system validation protocols, adhering to company procedures and regulatory expectations. Create equipment specifications and IQ plans and reports to support equipment installation and qualification process. Utilize statistics to analyse data, characterize process and perform process validation activities with support from Global team. Create quality system procedures and work with documentation control systems to create, manage and store documents Train and teach on concepts related to six sigma and lean manufacturing. Complete on time project updates, project hours, development plans, peerselfassessments, and successful completion of all training requirements. DESIREDPREFERRED QUALIFICATIONS Bachelor s in engineering or any advanced science degree. Working understanding of FDA, GMP, and ISO 13485. 6-8 years of work experience in the Medical Device Industry. Experience with basic statistics andor reliability methodologies.SDL2017

Keywords: Dew Software, San Jose , Process validation Engineer, Engineering , San Jose, California

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