Process Engineer – Lyophilization

ref. 01269

Process Engineer – Lyophilization

Overview:
We are seeking a Process Engineer for the ownership of design, procurement, installation, and commissioning of Lyophilization equipment and processes. In this role you will be responsible for ensuring that all aspects of the lyophilization process are efficient, cost-effective and compliant with regulatory standards.

Responsibilities

1. Process Design: Lyophilizer Package Owner
   Package owner responsible for design of the Lyophilizer. Prepares process and utility equipment specification sheets. Prepares detail design specification for all equipment. Reviews input from other disciplines for compatibility with the design process for all equipment. Understands importance of the equipment specification sheet as a communication tool with other disciplines.
2. Procurement: Identify and procure equipment and materials, ensuring that they comply with required specifications and standards.
3. Installation and Commissioning: Oversee the installation and commissioning of lyophilization equipment, ensuring it is correctly set up and fully operational.
4. Process Monitoring: Monitor and analyse process performance, adjusting as necessary to maintain product quality and consistency.
5. Troubleshooting: Identify and resolve issues related to the lyophilization process and equipment.
6. Regulatory Compliance: Ensure all processes comply with industry regulations and standards, including cGMP.
7. Documentation: Create and maintain detailed process design documentation, including P&ID’s, URS’s, equipment specifications and equipment package documentation.
8. Cross-Functional Collaboration: Work closely with other disciplines as the Requisition Engineer responsible for the Lyophilisation package.
9. Continuous Improvement: Implement process improvements to enhance efficiency, reduce costs, and improve product quality.

Qualifications

1. Bachelor’s degree in Chemical or Process Engineering.
2. Minimum of 3-5 years’ experience in process engineering, with a focus on lyophilization or related fields.
3. Awareness of process safety engineering and process safety management.
4. Significant design experience in the pharmaceutical sector relating to Lyophilisation.
5. Strong problem-solving abilities, excellent communication skills, and the ability to work effectively in a team environment.
6. Ability to work on own initiative.