Deskripsi Pekerjaan
Join YSS Laboratories Co., Inc. as a Validation Engineer and become a cornerstone of quality assurance in the healthcare industry. This pivotal role empowers you to drive product safety and regulatory compliance through rigorous equipment qualification, precision calibration, and data-driven validation protocols. You'll design and execute validation studies, analyze performance metrics to optimize processes, and ensure all systems meet stringent industry standards. Collaborate with cross-functional teams to implement robust validation strategies that enhance operational reliability while maintaining full compliance with GMP, FDA, and ISO requirements. Your expertise will directly impact product integrity and patient safety, making this an ideal opportunity for detail-oriented professionals passionate about quality excellence.
Tanggung Jawab
- Lead equipment qualification, calibration, and validation activities to ensure compliance with regulatory standards
- Develop and execute validation protocols for manufacturing processes and systems
- Analyze performance data to identify process improvements and ensure operational reliability
- Prepare comprehensive validation documentation, reports, and SOPs
- Coordinate with quality assurance and production teams to implement validation strategies
- Conduct risk assessments and deviation investigations related to validation processes
- Maintain and update validation systems, procedures, and equipment databases
Kualifikasi
- Bachelor's degree in Engineering, Chemistry, Biology, or related scientific field
- Minimum 2 years of experience in validation within healthcare or pharmaceutical industry
- Strong knowledge of GMP, FDA, and ISO regulatory requirements
- Proficiency in validation software and data analysis tools
- Excellent documentation and report writing skills
- Ability to interpret technical specifications and engineering drawings
- Strong problem-solving skills and attention to detail