Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
Reporting to the Senior Process & Technology Engineer, the Process & Technology Engineer is primarily responsible for supporting day-to-day production within the Biotools manufacturing areas and effectively implementing change management projects.
Duties
• Lead Process/Product Validations within the department as they arise, in conjunction with Quality/Validation/Operations groups. Prepare associated protocols, develop and execute plans and compile relevant reports as required.
• Provide day-day Technical support for processing issue or changes on existing manufacturing processes. Lead and coordinate the troubleshooting of various manufacturing process issues. usig 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 Merck 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.
• Working Knowledge of the following would be an advantage but not a requirement;
Automated / Semi Automated assembly equipment.
Injection moulding and mould tools.
High precision Punch & Die Sets. Heat sealing, ultrasonic welding, leak testing, vision systems.
OEE Line performance methodology.
Minitab/ Lean 6 Sigma techniques
AutoCAD
Who You Are
• 3+ years relevant experience, preferably within Medical Device industry or other regulated environments.
• Working knowledge of Product & Process validations essential
• Excellent verbal, written & 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 Orientated
• Demonstrate a high level of responsiveness to internal customers (eg. production)
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!