Kerja Sepenuh Masa, Process Engineer di Planet Pharma - Maukerja

Job Title – Process Engineer

Function – Manufacturing

Location – Singapore (Onsite)

About The Role

We are supporting a well-funded, clinically advanced biotechnology organisation to hire a Process Engineer within their Manufacturing team. The company is focused on developing next-generation biologics and cell-based therapies, with a strong pipeline and global partnerships already in place. This is an opportunity to join a high-growth environment where science and manufacturing are closely integrated, offering strong exposure to process development, scale-up, and technology transfer activities.

Key Responsibilities

Process Engineering

• Provide process input into engineering, qualification, and validation activities across new and existing advanced manufacturing facilities / processes in compliance
• Provide technical input for process fit assessments within existing manufacturing facilities and define process requirements for new facilities
• Provide ongoing technical support for change control, deviation investigations, and CAPA management during development and commercial manufacturing
• Ensure all manufacturing steps are reviewed and maintained in line with regulatory requirements
• Contribute to the manufacturing knowledge base, leveraging internal and external networks to identify best-in-class process technologies and solutions
  
  

Technology Transfer

• Support operational technology transfer from process development to cGMP manufacturing, including site-to-site transfers of commercial processes
• Monitor and analyse process-related data and site performance
• Assess critical raw material supply and suitability
• Implement process changes through formal change control processes and support execution at external manufacturing partners
• Track performance against project timelines and escalate risks or delays as required
  
  

Vendor Partnering

• Monitor and report on manufacturing processes and product output to ensure alignment with vendor agreements
• Coordinate internal teams and external manufacturing partners to deliver process and product technology transfers within agreed timelines
  
  

Health, Safety & Compliance

• Ensure adherence to all health and safety standards
• Identify and report risks or hazards
• Maintain compliance with internal policies and procedures
  
  

Requirements

• Bachelor’s degree in Life Sciences, Chemical Engineering, or related field
• Experience in biotech/pharmaceutical manufacturing environments
• Strong experience in change control, deviation investigations, and CAPA management
• Exposure to process development, scale-up, and manufacturing technology transfer
• Strong analytical and problem-solving skills
• Effective communication and stakeholder engagement skills
• Ability to work in a fast-paced, collaborative environment