Opportunity Description
Job Title: Validation Engineer
Job Description
The Validation Engineer leads process validation for automation and equipment capital projects, drives validation for new equipment installations and process improvements, and ensures seamless transfer of validated processes into production in a regulated medical device environment.
Responsibilities
+ Prepare, author, and execute validation documentation to ensure all automated systems and process improvements are fully validated (IQ/OQ/PQ) and compliant with 21 CFR Part 820 and other applicable standards prior to release to production.
+ Evaluate and define validation strategies that enable quick, robust, and compliant transfer of processes and equipment into production.
+ Maintain Agile-controlled process and equipment documentation, including standard operating procedures (SOPs), process flow charts, electrical drawings, 2D/3D equipment drawings, equipment parameter lists (CP), and equipment logic pro...
Job Description
The Validation Engineer leads process validation for automation and equipment capital projects, drives validation for new equipment installations and process improvements, and ensures seamless transfer of validated processes into production in a regulated medical device environment.
Responsibilities
+ Prepare, author, and execute validation documentation to ensure all automated systems and process improvements are fully validated (IQ/OQ/PQ) and compliant with 21 CFR Part 820 and other applicable standards prior to release to production.
+ Evaluate and define validation strategies that enable quick, robust, and compliant transfer of processes and equipment into production.
+ Maintain Agile-controlled process and equipment documentation, including standard operating procedures (SOPs), process flow charts, electrical drawings, 2D/3D equipment drawings, equipment parameter lists (CP), and equipment logic pro...
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