About Us
We are a global team that loves innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.
The Role
As a Process & Technology Engineer, you will report to the Senior Process & Technology Engineer and be primarily responsible for effectively implementing change management projects and supporting day-to-day production within the Biotools manufacturing areas.
Key Responsibilities:
* Lead Process/Product Validations within the department as they arise, in conjunction with Quality/Validation/Operations groups. Prepare associated protocols, develop and execute project plans, and compile relevant reports as required.
* Provide day-to-day Technical support for processing issues or changes on existing manufacturing processes. Lead and coordinate the troubleshooting of various manufacturing process issues using Root Cause Analysis methodology, and implementation of robust corrective and preventative actions.
* Lead investigations into process, product, and quality issues to achieve long-term solutions. This includes technical support and contact with external personnel and customers on process and product lines.
* Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
* Ensure compliance with GMP and Safety requirements on new and existing equipment.
* Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments. Identify and develop risk-based approach to change management in conjunction with validation and QA groups.
* Conduct feasibility trials/process DOE's to determine appropriate/robust process windows.
Requirements
To succeed in this role, you will need:
* Bachelor's degree in Mechanical/BioMedical/Process Engineering or similar
* 3+ years relevant experience, preferably within Medical Device industry or other regulated environments
* Working knowledge of Product & Process validations essential
* Excellent verbal, written, and interpersonal communication skills
* Process-driven and experienced in standardizing and simplifying work processes
* Leadership & Influencing Skills
* Excellent engineering ability
* Good stakeholder management skills across all levels
* Experience in working in a complex matrix organization
* Team Oriented
* Demonstrate a high level of responsiveness to internal customers (e.g. production)
About Our Culture
We celebrate diversity and believe it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfill your ambitions.