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