job description
Join Becton Dickinson (BD), a global leader in medical technology, as a Validation Engineer in our dynamic team based in Bali, Indonesia. In this critical role, you will ensure the reliability, compliance, and performance of our cutting-edge medical systems and devices through rigorous testing, data analysis, and validation processes.
As a Validation Engineer, you will play a pivotal role in maintaining the highest standards of quality and regulatory compliance, contributing directly to BD’s mission of advancing healthcare worldwide. Your expertise in performance testing, system validation, and compliance frameworks will drive the success of our life-saving technologies.
This is an exceptional opportunity for a detail-oriented professional with a passion for precision and a commitment to excellence in the medical device industry.
Responsibility
- Design, develop, and execute validation protocols for medical devices and systems to ensure compliance with global regulatory standards (e.g., FDA, ISO 13485, CE Marking).
- Conduct performance testing, risk assessments, and data analysis to verify system reliability, accuracy, and safety.
- Document validation processes, test results, and deviations in accordance with Good Documentation Practices (GDP).
- Collaborate with cross-functional teams (R&D, Quality Assurance, Manufacturing) to identify validation requirements and resolve technical issues.
- Perform equipment qualification (IQ/OQ/PQ) and software validation for medical device systems.
- Support audit preparations and respond to regulatory inquiries related to validation activities.
- Continuously improve validation methodologies and tools to enhance efficiency and compliance.
- Stay updated on industry trends, regulatory changes, and emerging technologies in medical device validation.
Qualifications
- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field. Advanced degrees are a plus.
- Minimum 3-5 years of experience in validation engineering, preferably in the medical device or pharmaceutical industry.
- Strong knowledge of regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5, EU MDR).
- Proven expertise in performance testing, data analysis, and statistical methods (e.g., DOE, SPC).
- Experience with validation software tools (e.g., LabVIEW, MATLAB, or PLM systems) and test equipment.
- Excellent technical writing skills for creating validation protocols, reports, and SOPs.
- Strong problem-solving, analytical, and project management skills with attention to detail.
- Ability to work in a fast-paced, regulated environment and meet tight deadlines.