Job Purpose
- Provides technical supply support on the commercialization and manufacture of products either independently or with minimal support (seeking support / escalating efficiently where needed).
- Supports/ leads all technical/ process activities (for example) investigations, validation and qualification processes, risks assessments, process safety management activities under his/ her responsibilities and could be responsible for technical product stewardship activities.
- Supports continuous process improvement activities to enhance site performance metrics and contributes to the global organization technical network to share site experiences/ knowledge and continuously expands on personal expertise.
- Supports/leads the introduction of new products to the site and the transfer of products to other facilities.
Responsibilities
- Lead and support new product introductions, including process scale-up, equipment qualification (IQ/OQ/PQ), PPQ execution, and validation documentation for sterile medical devices/pharmaceutical manufacturing
- Design and execute process experiments to evaluate equipment and process changes, troubleshoot manufacturing issues, and implement improvements to ensure robust and compliant operations
- Provide technical support for sterile manufacturing, including monitoring CPPs, CQAs, Cpk, and sterile boundaries to maintain validated state and product quality
- Investigate deviations, product complaints, and adverse events to determine root causes and implement effective CAPA in compliance with GMP requirements.
- Support regulatory audits, change control management, cleaning validation, continued process verification, and lifecycle management activities within a pharmaceutical manufacturing environment
Requirements:
- Bachelor's degree in chemical or mechanical engineering, Chemistry, Biological sciences, or Pharmaceutical Sciences
- At least 3 years experience in the process engineering with hands-on experience in equipment validation and sterile manufacturing
All qualified candidates please send your resume to [Confidential Information]
Anna Chen jiaxin
CEI No: R25157621
Recruit Express Pte Ltd
EA License: 99C4599
