/lifesciences settings. Maintain GxP standards, CSV processes, and FDA 21 CFR Part 11 regulations. Conduct functional...), or lifesciences software. Handle full STLC with tools like JIRA, Client ALM, or Codebeamer for test management. Embed...
Roles & Responsibilities: Primary responsibilities include computerized system validation and computerized equipment qualification. Strong working knowledge of Quality System Regulations. Experience leading CAPA (Corrective and Preventi...
Job Summary: Validation Engineer - Manufacturing Operations responsible for overseeing complex production processes for surgical devices, leading validation activities, troubleshooting electro-mechanical systems, and ensuring manufacturin...
environments Bachelor's degree in Engineering, LifeSciences, or a related field required 5-7 years of experience in validation...
Roles & Responsibilities: Prior JNJ TQ Experience a must Experience in validating QMS and different modules in QMS 5+years' experience with System Development Lifecyle 10+years' experience in Computer System Validation (Base...
experience with Unix and Windows operating systems Understanding of the software development life cycle Understanding of FDA...
Job Description: Performs any combination of tasks involved in the manufacture and assembly of medical devices as well as setting up, operating, performing maintenance on and troubleshooting equipment. Responsibilities: Responsible for ...
documentation Experience: Previous experience as a CSV Engineer supporting commissioning activities on lifesciences construction...
Job Summary: They are interested in temperature mapping experience, specifically CTUs, stability chambers, or similar environments. Strong lab instrument experience. 5+years of hands-on CSV in GxP environments. Experience with ris...
Job Summary: The Mechanical Project Development Engineer is responsible for designing and developing complex medical device components by translating engineering requirements into high-quality, compliant design solutions with limited supe...