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 Engineer will be responsible for managing project and process engineering requirements through technology transfer and commercialization in a new manufacturing facility.
Duties:
• Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments on changes in processes and equipment as part of the tech transfer.
• Become SME for the relevant manufacturing processes under the Process engineer’s ownership.
• Support Equipment Validations, in conjunction with Quality/Validation group. • Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows.
• Prepare & execute OQ / PQ protocols for process / material changes as needed.
• Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
• Complete Process / Product Validations in conjunction with Quality/Validation group.
• Liaise with operations and other departments to prepare plan for validation builds.
• Co-ordinate the execution of OQ / PQ builds.
• Prepare OQ / PQ validation reports and deviations as required.
• Conduct process capability analysis using Minitab.
• Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
• Provide Technical/Engineering support to manufacturing.
• Provide day-day Technical support for processing issue 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 and coordinate the troubleshooting of various manufacturing process issues.
• Responsible for dealing with process, product and quality issues to achieve long term solutions.
• Support the various groups: quality, validation, maintenance, EHS etc to achieve objectives.
• 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.
• Ensure compliance with GMP and Safety requirements on new and existing equipment.
• Working Knowledge of the following would be an advantage but not a requirement;
• Automated / Semi Automated assembly equipment.
• Injection molding and mold tools.
• Heat sealing, ultrasonic welding, leak testing, vision systems.
• OEE Line performance methodology.
• Minitab/ Lean 6 Sigma techniques
• AutoCAD
• Demonstrated Commitment to Safety and Quality.
• Automated control loop design and optimization
• Microbiological requirements in GMP manufacturing
• Use of ERP Systems eg. SAP or equivalent systems
Who You Are
Bachelor’s degree in Mechanical / BioMedical/ Process Engineering or similar
A postgraduate qualification in one of these disciplines would be an advantage.
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)
Strong organisational, time management and planning ability.
Computer literate Excel, Word, Powerpoint etc
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!
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