Job Summary:
The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes lead and/or execute validation activities, including equipment, process, test method and software validation, to ensure that products are manufactured consistently and reliably in accordance with Good Manufacturing Practices (GMP) and other relevant standards.
Essential Duties and Responsibilities:
Include the following. Other duties may be assigned.
Validation Planning and Execution:
- Discuss and develop Master Validation Plan with the engineering / NPI team during the NPI process.
- Develop, implement, and maintain validation protocols and procedures for equipment, processes, and systems in accordance with regulatory requirements and industry best practices.
- Lead the execution of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.Establish and execute the Test Method Validation.
- Exercise authority to make technical decisions related to validation activities and methodologies.
- Perform risk assessments to identify critical areas and establish validation strategies.
- Ensure the re-validation and periodic review is conducted in a timely manner.
Documentation and Reporting:
- Prepare and review detailed validation documentation, including validation plans, protocols, reports, and change control documents.
- Maintain and update the Master Validation Plan as and when required.
- Authorize and approve validation documents and reports prepared by other team members.
- Maintain accurate and complete records of validation activities and results.
Compliance and Quality Assurance:
- Ensure validation activities comply with FDA regulations, ISO standards (e.g., ISO 13485), and other relevant guidelines.
- Support internal and external audits and regulatory inspections.
- Investigate and resolve validation-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
Cross-functional Collaboration:
- Collaborate with engineering, manufacturing, and quality assurance teams to ensure seamless integration of validated systems and processes.
- Provide validation expertise and exercise authority in decision-making during the development and implementation of new processes, equipment, and technologies.
- Oversee and support the training of personnel on validation procedures and best practices.
Continuous Improvement:
- Identify opportunities for process improvements and efficiency gains within the validation scope.
- Stay current with industry trends, technological advancements, and regulatory changes related to validation and medical device manufacturing.
- Implement improvements and best practices within the validation framework, with the authority to drive change.
