We are seeking a highly skilled and detail-oriented Manufacturing Engineer to join our dynamic team in the life sciences sector. The Manufacturing Engineer will play a critical role in supporting the manufacturing operations, ensuring that production processes are efficient, reliable, and in compliance with stringent regulatory standards. This position will involve a combination of process optimization, troubleshooting, equipment management, and collaboration with cross-functional teams to ensure the seamless production of high-quality life sciences products.

As a Manufacturing Engineer, you will work to design, implement, and improve manufacturing processes while ensuring compliance with GMP (Good Manufacturing Practices), regulatory requirements, and company policies. You will be instrumental in increasing production efficiency, improving product quality, and maintaining a safe and effective manufacturing environment.

The Role

Process Design and Optimisation:

• Design, implement, and optimize manufacturing processes for life sciences products, ensuring high quality, efficiency, and cost-effectiveness.
• Identify areas for process improvement and work with cross-functional teams to implement solutions that increase productivity, reduce waste, and enhance product quality.
• Develop process flow diagrams, work instructions, and standard operating procedures (SOPs) for manufacturing operations.

Troubleshooting and Problem Solving:

• Troubleshoot and resolve manufacturing issues, including equipment malfunctions, process deviations, and quality concerns.
• Analyse root causes of manufacturing problems and develop corrective and preventive actions (CAPAs) to prevent recurrence.
• Work with quality assurance and regulatory teams to ensure that all issues are addressed in accordance with compliance standards.

Equipment and Facility Management:

• Ensure the proper selection, installation, calibration, and maintenance of manufacturing equipment.
• Perform equipment qualification (IQ/OQ/PQ) and support the development of maintenance plans to ensure equipment operates at peak performance.
• Collaborate with maintenance teams to minimise downtime and optimise machine uptime.

Regulatory Compliance and Quality Assurance:

• Ensure that manufacturing processes adhere to industry-specific regulatory standards such as FDA, ISO 13485, GMP, and other relevant guidelines.
• Support internal and external audits, ensuring compliance with all relevant regulations and standards.
• Work with the quality assurance team to maintain high standards of product quality through process validation, documentation, and adherence to SOPs.

To discover more about this opportunity please apply online or contact Darragh on +353 87 934 5234 for a confidential discussion.