Process Engineer in BioPharma
We are seeking a dynamic Process Engineer to support daily manufacturing functions and drive continuous improvement in pre-filled syringe processes.
Key Responsibilities:
* Process Development and Optimization: Filter test development and optimization of fill weight cycles, cleaning verification to ensure high operational hygiene standards.
* Lead technical investigations and implement corrective actions for process-related issues.
* Documentation and Compliance: Develop and execute key process documents including protocols, reports, recipes, and Failure Mode Effect Analysis (FMEAs).
* Author operational control strategy documents and facilitate operator training.
Requirements:
* Honours degree in an Engineering discipline.
* 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.
Attributes:
* Strong project management and communication skills.
* Ability to collaborate across departments and with external vendors.
* A proactive, innovative approach to problem-solving.
This role offers the opportunity to work in a collaborative and high-performing engineering team in a cutting-edge sterile manufacturing environment.
The successful candidate will have a strong understanding of pharmaceutical processes and a passion for driving continuous improvement.