Process and Technology Engineer

2 months ago

Cork, Cork, Ireland Cpl Full time

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 head of R&D, Molecular Reagents and Tools, the Process & Technology Engineer is primarily responsible for introduction of new products into market along with supporting manufacturing areas for effectively implementing change management projects.

Duties


• Provide process & technology expertise to support launch of new SLS-Biology products manufactured in Cork, Ireland.


• 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.


• Work closely with quality to come up with validation master plan for launch of new products.


• Conduct process feasibility trials / process DOE's to determine appropriate/robust process windows.


• 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.


• 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.


• 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.


• 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

Bachelor's degree in Mechanical / BioMedical/ Process Engineering or similar

2-3 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)

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