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
