Deskripsi Pekerjaan
National Institutes of Biotechnology Malaysia (NIBM) is a premier government research agency dedicated to advancing biotechnology and industrial standards. We invite qualified, experienced, dynamic, and work-ready individuals to join our team as a Technology Officer (GMP Engineer). In this pivotal role, you will ensure our facility operates in strict accordance with Good Manufacturing Practice (GMP) standards, guaranteeing the highest quality of biotechnological products and research integrity. If you are passionate about engineering excellence, quality assurance, and working in a cutting-edge research environment, we encourage you to apply.
Tanggung Jawab
- Oversee and ensure strict compliance with Good Manufacturing Practice (GMP) regulations and standard operating procedures (SOPs) across all technical operations.
- Manage the maintenance, calibration, and troubleshooting of laboratory and manufacturing equipment to ensure optimal performance and safety.
- Prepare and maintain accurate technical documentation, including batch records, validation reports, and change control logs.
- Conduct internal quality audits and inspections to identify non-conformities and implement corrective and preventive actions (CAPA).
- Coordinate with cross-functional teams to support process validation, scale-up, and technology transfer projects.
- Train staff on technical protocols, equipment usage, and GMP compliance requirements to foster a culture of quality.
- Monitor utility systems (e.g., HVAC, water systems) to ensure they meet operational and regulatory specifications.
Kualifikasi
- Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related scientific field.
- Minimum of 2 years of relevant work experience in a GMP-compliant environment, preferably within the pharmaceutical or biotechnology industry.
- Familiarity with quality management systems, equipment validation (IQ/OQ/PQ), and documentation standards.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Proficiency in using technical software, MS Office Suite, and standard engineering tools.
- Excellent communication skills and the ability to work effectively in a team-oriented, fast-paced environment.