Validation Engineer Job Description

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Validation Engineer Job Description

 

Job Title: Validation Engineer

 

Job Summary:

We are seeking a skilled Validation Engineer to ensure that our products and processes meet regulatory requirements and industry standards. The successful candidate will be responsible for developing and executing validation plans, protocols, and reports for equipment, systems, and processes. The ideal candidate will have strong technical skills, excellent attention to detail, and the ability to work collaboratively with cross-functional teams.

 

Responsibilities:

 

     Develop and execute validation plans, protocols, and reports for equipment, systems, and processes

     Ensure that all validation activities are in compliance with regulatory requirements and industry standards

     Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure that validation requirements are met

     Perform risk assessments to identify and mitigate potential validation issues

     Review and approve validation documentation, including protocols, reports, and test data

     Develop and maintain standard operating procedures for validation activities

     Provide technical guidance to project teams to ensure that validation requirements are met

     Participate in audits and inspections to ensure that validation activities are in compliance with regulations and standards

     Stay current with industry trends and technologies to identify opportunities for innovation and system improvements

 

Requirements:

 

     Bachelor's degree in Engineering or a related field

     Minimum of 3 years of experience in validation engineering

     Strong technical skills in validation protocols and testing methodologies

     Familiarity with regulatory requirements and industry standards for validation, such as FDA regulations and ISO standards

     Excellent communication and interpersonal skills

     Ability to work independently and manage multiple projects simultaneously

     Strong analytical and problem-solving skills

     Experience with project management and documentation

     Knowledge of manufacturing processes and equipment

     Experience with statistical analysis software, such as Minitab or JMP, preferred