Deskripsi Pekerjaan
Are you a passionate Manufacturing Engineer with a deep expertise in Upstream Process Automation? We are looking for a dedicated SME to drive production excellence and spearhead digital transformation initiatives within our state-of-the-art facility in Tuas. In this pivotal role, you will bridge the gap between traditional GMP manufacturing and cutting-edge automation technologies to optimize bioprocess efficiency and ensure regulatory compliance.
You will be responsible for leading technical improvements in upstream bioreactor operations, implementing automated control systems, and troubleshooting complex process challenges. This is an excellent opportunity for a technical leader to make a significant impact on our manufacturing capabilities while working in a collaborative and innovative environment.
Tanggung Jawab
- Drive and optimize upstream bioprocess equipment performance, including bioreactors and ancillary systems, to ensure high production yield and quality.
- Lead the implementation, validation, and maintenance of automation solutions (PLC, SCADA, DCS) to support digital transformation goals.
- Ensure strict adherence to GMP regulations, cGMP standards, and internal quality systems during all manufacturing activities.
- Collaborate cross-functionally with R&D, Production, and Quality Assurance teams to define and execute process improvement projects.
- Troubleshoot complex manufacturing issues and implement corrective actions to minimize downtime and ensure continuous operations.
- Develop and maintain Standard Operating Procedures (SOPs) and technical documentation related to process control and automation.
- Act as the Subject Matter Expert (SME) for upstream automation, mentoring junior engineers and providing technical guidance.
Kualifikasi
- Bachelor’s degree in Chemical Engineering, Biotechnology, or a related engineering discipline.
- Minimum of 3-5 years of hands-on experience in Upstream bioprocessing within a GMP-regulated environment.
- Strong working knowledge of process automation systems (e.g., Siemens, Rockwell, or equivalent).
- Deep understanding of GMP regulations, data integrity requirements, and quality systems.
- Proven track record in process optimization, troubleshooting, and capital project execution.
- Excellent problem-solving skills and the ability to work effectively in a fast-paced, team-oriented setting.