Headcount Solutions are recruiting a Process Engineer for one of our leading multinational clients site in Cork, The Process Engineer for Lyophilization is responsible for the design, procurement, installation, and commissioning of lyophilizer equipment and processes.
This role ensures that all aspects of the lyophilization process are efficient, cost-effective, and compliant with regulatory standards.
Key Responsibilities: Process Design: Lyophilizer Package Owner •Prepares process and utility equipment specification sheets.
Package owner responsible for design of the Lyophilizer.
•Understands importance of the equipment specification sheet as a communication tool with other disciplines.
•Prepares detail design specification for all equipment.
•Reviews input from other disciplines for compatibility with process design for all equipment.
Procurement: Identify and procure equipment and materials, ensuring they meet the required specifications and standards Installation and Commissioning: Oversee the installation and commissioning of lyophilization equipment, ensuring it is correctly set up and fully operational.
Process Monitoring: Monitor and analyse process performance, adjusting as necessary to maintain product quality and consistency.
Troubleshooting: Identify and resolve issues related to the lyophilization process and equipment.
Regulatory Compliance: Ensure all processes comply with industry regulations and standards, including GMP (Good Manufacturing Practices).
Documentation: Create and maintain detailed process design documentation, including P&ID's, URS's, equipment specifications and equipment package documentation.
Cross-Functional Collaboration: Work closely with other disciplines as the Requisition Engineer responsible for the Lyophilisation package Continuous Improvement: Implement process improvements to enhance efficiency, reduce costs, and improve product quality.
Qualifications: Bachelor's degree in Chemical or Process Engineering Minimum of 3-5 years of experience in process engineering, with a focus on lyophilization or related fields.
Awareness of process safety engineering and process safety management Significant design experience in the pharmaceutical sector relating to Lyophilisation