Validation Engineer
Apply NowCompany: Libsys, Inc.
Location: Redwood City, CA 94061
Description:
Project Summary: Line Validation at new San Jose Facility. The Manufacturing Test Engineer would be responsible for process validation activities. Development and validation of test methods at the new facility in San Jose may also be needed. The Consultant would work in RedWood City for the first 3-4 weeks, with some travel required to San Jose. Later on I would need to work out of San Jose.. Specific responsibilities for this role would include:
Process and equipment qualification (IQ/OQ/PQ).
Development of test methods for Design V&V, Process Validation, and Production Validation of test methods
Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work Authoring/releasing of new test methods and editing/redlining of old test methods Additional tasks may be assigned outside the scope of this specific project, but all will be related to Test Engineering
The education/experience I am looking for is as follows:
This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
Manufacturing Engineering experience.
Experience with Test Method Validation and/or Measurement System Analysis is preferred.
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
Strong organizational skills, detail oriented.
Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
Ability to work to a deadline and to handle multiple tasks simultaneously.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
Process and equipment qualification (IQ/OQ/PQ).
Development of test methods for Design V&V, Process Validation, and Production Validation of test methods
Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work Authoring/releasing of new test methods and editing/redlining of old test methods Additional tasks may be assigned outside the scope of this specific project, but all will be related to Test Engineering
The education/experience I am looking for is as follows:
This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
Manufacturing Engineering experience.
Experience with Test Method Validation and/or Measurement System Analysis is preferred.
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
Strong organizational skills, detail oriented.
Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
Ability to work to a deadline and to handle multiple tasks simultaneously.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.