Deskripsi Pekerjaan
Wuxi Biologics is a world-leading biologics CRDMO (Contract Research, Development, and Manufacturing Organization) dedicated to helping our partners accelerate their drug discovery and development programs. We are currently seeking a highly motivated and detail-oriented Formulation / Parts Preparation Engineer, Drug Product to join our dynamic team in Tuas, Singapore.
This role will ensure smooth day-to-day manufacturing floor operations, with a strong focus on the compliant execution of critical aseptic processes. You will be an integral part of our drug product manufacturing operations, ensuring the flawless execution of formulation and parts preparation activities. You will work within a state-of-the-art facility, strictly adhering to current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs) to deliver high-quality biologics to patients worldwide.
As a key member of the engineering team, you will be responsible for maintaining the highest standards of aseptic technique, optimizing process workflows, and troubleshooting equipment issues to ensure seamless daily operations. Your expertise will directly impact the efficiency, safety, and compliance of our manufacturing floor.
If you are passionate about biopharmaceutical manufacturing and possess a strong background in drug product formulation or aseptic processing, we invite you to apply and grow your career with Wuxi Biologics.
Tanggung Jawab
- Ensure smooth day-to-day manufacturing floor operations with a strong focus on the compliant execution of critical aseptic processes.
- Execute and troubleshoot formulation, compounding, and parts preparation activities for drug product manufacturing according to batch records and SOPs.
- Prepare, sterilize, and manage parts and components (e.g., stoppers, vials, filters, tubing sets) ensuring readiness for filling operations.
- Support the setup, operation, and cleaning of process equipment such as mixers, autoclaves, vial washers, and filling lines.
- Author, review, and maintain accurate batch records, logbooks, and standard operating procedures (SOPs) in compliance with regulatory standards.
- Investigate and resolve process deviations, participating in root cause analysis (RCA) and implementation of corrective and preventive actions (CAPA).
- Collaborate closely with cross-functional teams (Quality Assurance, Process Development, Maintenance) to optimize manufacturing processes.
- Participate in equipment qualification, process validation, and technology transfer initiatives to support new product introductions.
Kualifikasi
- Bachelor's Degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related scientific discipline.
- Minimum 2 to 5 years of hands-on experience in aseptic manufacturing within the pharmaceutical or biotechnology industry.
- Strong understanding of cGMP regulations, aseptic processing principles, and environmental monitoring requirements.
- Proven experience in parts preparation, component management, and formulation in a parenteral drug product facility.
- Excellent written and verbal communication skills, with a strong focus on documentation and attention to detail.
- Demonstrated ability to work effectively in a team-oriented, high-paced manufacturing environment.
- Experience supporting regulatory inspections (e.g., FDA, HSA, PMDA) is highly advantageous.
- Willingness to work in a cleanroom environment and flexible to support rotating shifts or extended hours as needed.