This person is responsible for leading validation teams' efforts to ensure systems and processes comply with industry standards and regulatory requirements. This role involves leading validation activities, developing strategies, executing test plans, analyzing data, and providing technical expertise.
Key Responsibilities
* Provide technical oversight, leading the overall validation & qualification of equipment and processes in collaboration with colleagues.
* Lead, support, guide, and coordinate validation activities with team members to ensure adequate resource assignment, task prioritization, and progress monitoring.
* Collaborate with Manufacturing Engineering, Operations, Quality Assurance, and Regulatory teams to define validation requirements.
* Support Regulatory Affairs with submissions to regulatory bodies and associated inquiries.
* Guide the team in transitioning from semi-manual to automated validation methodologies, including the development of necessary validation and CSV documentation.
* Develop and implement validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
* Implement and coordinate the change control process, promoting timely approval of all supporting documentation.
* Ensure compliance with industry regulations such as FDA, GMP, or other relevant standards.
* Design and execute test plans, analyze results, and document findings in technical reports.
* Provide technical leadership in troubleshooting validation-related issues and drive continuous improvement initiatives.
* Maintain detailed documentation of validation activities and ensure traceability of validation data.
* Mentor junior engineers and team members in validation methodologies and best practices.
Required Qualifications & Experience
* Bachelor's or master's degree in engineering, Science, or a related field.
* Minimum of 5-7 years of experience in validation engineering, preferably in medical devices.
* Strong understanding of validation principles, regulatory requirements, and statistical analysis tools.
* Hands-on experience with test methodologies, software validation, and process validation.
* Strong analytical skills and problem-solving abilities.
* Excellent communication and project management skills.