Job Summary:
The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet the required quality standards and regulatory requirements. This role includes leading and/or executing validation activitiessuch as equipment, process, test method, and software validationto ensure products are manufactured consistently and reliably in accordance with Good Manufacturing Practices (GMP) and other relevant standards.
Essential Duties and Responsibilities:
The following list includes primary responsibilities. Additional duties may be assigned as necessary.
Validation Planning and Execution:
- Develop and discuss the 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 validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.
- Establish and execute Test Method Validation.
- Exercise authority in making technical decisions related to validation activities and methodologies.
- Perform risk assessments to identify critical areas and develop validation strategies.
- Ensure re-validation and periodic review are 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 needed.
- 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 the 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.
Education/Experience and Qualifications:
- Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing. Diploma holders in Engineering or science with more than 5 years experience in Quality may be considered.
- Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
- Good command of English language.
- Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.
- Able to effectively collaborate with cross-functional teams and present information clearly.
