Process Engineer (Equipment Validation/ Pharma)
Duration: 6 months
Location: Tuas
Salary : Up to $7,500 depending on experience
Our Client is a US MNC and a pioneering leader in the Pharmaceutical industry. They are currently seeking experienced and forward-thinking professionals to join their team in Singapore
Job Purpose
- Provides technical supply support on the commercialization and manufacture of all drug 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 drug 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 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
- Experience in the Pharmaceutical Manufacturing Industry
Lim Pey Chyi - [Confidential Information]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Desired Skills and Experience
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
Experience in the Pharmaceutical Manufacturing Industry
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579
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