Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Validation Engineers III, Organogenesis, Inc., HQ in Canton, MA; Main worksite office at 150 Dan Road, Canton, MA 02021: The Validation Engineer III will be responsible for overall support of validation activities and developing test protocols for the qualification of various types of cGMP equipment, processes and system, developed/approved protocols, and will utilize knowledge of industry standard in engineering, industrial science and quality/regulatory requirement to ensure compliance. Key Responsibilities: Support validation activities at our offices in Canton, MA and may report to our facility in Norwood, MA on an as-needed basis; Prepares all protocols and reports for validation and revalidation work; Coordinates and executes validation studies for lab and testing equipment; Performs testing using standard concepts, practices and procedures of the cGMP processes; Reviews and summarizes equipment history files to assess the validated state of equipment; Adjusts equipment or processes that require improvement and/or repair; Performs a variety of validation tasks and projects outside classical validation tasks and applies diverse engineering development skills in a creative manner in order to increase operational efficiencies and product quality; Creates and/or reviews Standard Operating Procedures (SOPs) for system projects. Minimum requirements: Master’s degree in Industrial Management, Industrial Engineering, Validation Engineering, or a closely related field of study (foreign equivalent degrees accepted) and 1 year of experience in any related occupation validating cGMP systems; or, in the alternative, a Bachelor’s degree in Industrial Management, Industrial Engineering, Validation Engineering, or a closely related field of study (foreign equivalent degrees accepted) and 5 years of progressive experience in any related occupation validating cGMP systems. Basic pay is one hundred twenty-seven thousand, eight hundred and fifty-eight dollars for full-time employment and standard company benefits.
Qualified applicants should mail resumes to Cathy Bates, Senior Talent Specialist, Organogenesis Inc., 85 Dan Road, Canton, MA 02021 or send via email to TalentAcquisition@organo.com with reference to Job Code: ORGAK2024. No calls please.
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