Validation Engineer - #1096665

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.

Authority:

•      Authority to approve and validate equipment, processes, and systems used in the production of medical devices.

•      Authority to recommend and implement corrective and preventive actions based on validation findings.

•      Authority to lead cross-functional teams in validation activities and make decisions regarding validation strategy and execution.

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.