We are driven to unlock information and insights that drive better health outcomes.
Our ambitious team uses sound engineering principles to implement, characterize, improve, and qualify manufacturing processes.
About The Role
You will use structured problem-solving techniques to root cause analysis and identify process risks in our highly automated manufacturing environment.
* Monitor, analyse, and improve Overall Equipment Effectiveness (OEE) across a scale-up of new or existing products.
* Support equipment and process qualifications, including protocol development, execution, and documentation for replicating manufacturing processes.
* Apply industry-standard analysis of data, and present findings to technical teams.
* Collaborate with suppliers to ensure equipment, materials, and components meet product specifications and performance requirements.
* Work with engineering, quality, and operations teams to implement continuous improvement initiatives.
You will be responsible for ensuring compliance with FDA design controls and documentation standards.
Your Key Responsibilities
* OEE Improvement: Analyze and optimize Overall Equipment Effectiveness across various production lines.
* Process Qualifications: Develop, execute, and document qualification protocols for manufacturing processes and equipment.
* Risk Management: Identify, assess, and mitigate potential risks associated with process and equipment changes.
* Supplier Collaboration: Work closely with suppliers to guarantee the quality and reliability of equipment, materials, and components.
What You Need To Succeed
* Proven experience in manufacturing process engineering or related field.
* Strong analytical and problem-solving skills.
* Excellent communication and collaboration skills.
* Familiarity with FDA design controls and documentation standards.