Process Engineer (Equipment Validation/ Pharma)

Duration: 6 months Contract

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 – [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423