Deskripsi Pekerjaan
Are you a detail-oriented Microbiologist looking for an opportunity to make a significant impact in the pharmaceutical industry? Thermo Fisher Scientific is seeking a dedicated Microbiologist II to join our dynamic team in Joo Koon. In this role, you will play a critical part in ensuring product quality and safety through rigorous GMP Quality Control testing and environmental monitoring. You will work in a state-of-the-art cleanroom environment, adhering to strict regulatory standards while contributing to method validation and process compliance. This position offers the unique advantage of a 12-hour rotating shift, providing a great work-life balance and comprehensive benefits. If you are passionate about science and compliance, we want to hear from you.
Tanggung Jawab
- Perform routine and non-routine GMP Quality Control testing on raw materials, in-process materials, and finished products.
- Conduct environmental monitoring (air, surface, personnel) in controlled cleanroom environments to ensure compliance with regulatory standards.
- Participate in method validation, transfer, and verification activities to ensure analytical accuracy.
- Maintain accurate and complete batch records, raw data, and deviation reports in accordance with Good Manufacturing Practices (GMP).
- Assist in internal and external audits by preparing documentation and supporting the QA team.
- Investigate out-of-specification (OOS) results and root cause analysis for microbiological issues.
Kualifikasi
- Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field.
- Minimum of 2-4 years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Experience working in a cleanroom setting is strongly preferred.
- Ability to work rotating shifts, including nights and weekends, for 12-hour shifts.
- Strong attention to detail and excellent problem-solving skills.
- Familiarity with aseptic techniques and microbiological media preparation.
- Proficiency in using laboratory information management systems (LIMS) is a plus.