Lead Process Engineer
Matrix Recruitment
Waterford
What you need to knowYou will work as a Lead Process Engineer for our client, a pharmaceutical company in the Waterford area … You will provide Engineering support in the development, operation and improvement of processes associated with aseptic Fill Finish and Lyophilization. This is a permanent job. Salary will reflect relevant experience. Your new job Key duties & responsibilities: Engineering: Equipment Functionality. Understanding equipment operation in detail. Defining and reviewing equipment specification and associated test documentation. Support project delivery through FAT, SAT and IOQ involvement as needed. Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing. Strong focus on disciplined root cause analysis. Process. Liaising with vendors on pre-sterilized components. Defining specifications and test requirements. Liaising with vendors on disposable technology and integration into the process. Defining specification and test requirements. Development of process cleaning and sterilization cycles. Development of procedures and controls for High Containment applications. Development of critical process parameters for the process and development of process capability and deviation monitoring. Monitoring process risk and ensuring mitigations are in place as required. Implementation of data monitoring systems to ensure process control. What are we looking for? Higher degree level in engineering or related discipline. Minimum 5 year’s engineering experience within a relevant Pharma environment (preferably within a sterile manufacturing environment. Knowledge of sterile and isolator technologies (including disposable technologies). Have an expertise in Fill Finish critical process parameters and product quality attributes. Experience in Cycle development and validation for sterile manufacturing. cGMP Compliance. Apply for this job now or get in touch with Patricia on 059 9139070. Matrix Recruitment Group is committed to providing a professional service where all CV''s are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent. This job originally appeared on RecruitIreland.com.
2759 days ago