Job Title: Process Engineer
We are seeking a dynamic Process Engineer to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes.
In this role, you will be essential to the production of monoclonal antibody (mAb) products, technology transfer, and capacity expansion.
You will join a collaborative and high-performing engineering team working in a cutting-edge sterile manufacturing environment.
Key Responsibilities:
* Process Development and Optimization:
o Filter test development and optimization of fill weight cycles
o Cleaning verification to ensure high operational hygiene standards
o Lead technical investigations and implement corrective actions for process-related issues
* Documentation and Compliance:
o Develop and execute key process documents including protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs)
o Author operational control strategy documents and facilitate operator training
* Project Management and Coordination:
o Manage deliverables to meet project timelines and budgets
o Generate detailed schedules for production activities and project planning
* Operational and Vendor Support:
o Support syringe filling processes involving critical equipment such as debaggers, Ebeam, delid/deline systems, isolators, and syringe filling machines
o Liaise with material/component vendors to ensure proper integration and execution of projects
* Safety and Compliance:
o Ensure compliance with Good Manufacturing Practices (cGMP) and safety standards
o Participate in regulatory and safety audits and maintain an audit-ready work environment
Requirements:
* Educational Requirements: Honours degree in an Engineering discipline
* Experience and Skills: 3+ years of relevant experience in a regulated GMP environment
* Strong problem-solving and troubleshooting abilities
* Prior experience in sterile manufacturing and syringe filling is an advantage
* Experience in new product introductions or technology transfers is highly beneficial
Attributes:
* Strong project management and communication skills
* Ability to collaborate across departments and with external vendors
* A proactive, innovative approach to problem-solving