Equipment Process Engineer

Fastnet The Talent Group

Sligo

Fastnet The Talent Group are currently recruiting for an Equipment Process Lyophilization Engineer with a leading Biopharma client based in Sligo. Excellent opportunity, technician with Lyo expeirence also considered. In this role, you will. Will be site engineering Subject Matter Exper t for IMA Lyomax Freeze Drying equipment from design phase to sustaining operations. Defining and reviewing equipment specification and associated test documentation. Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing, containment. Strong focus on disciplined Root cause analysis. Maintenance of process cleaning and sterilization cycles for new product introductions. Coordinate the training of engineering/operations personnel on all technology and process, ensuring cGMP compliance. Coordinating Facilities / Utilities Requirements. Setup and maintain manufacturing area equipment in compliance with the calibration and maintenance programs. Qualifications: Third level honours degree in Science/Engineering based discipline. Minimum of 5 years' experience in Freeze Dryers, Autoclave; Steam in Place (SIP) / Clean in Place (CIP) skids. Will have an extensive knowledge and experience with Freeze Driers, ideally IMA based units. Experience with commissioning, and validation of Lyophilisation equipment. Will have a high level of proficiency in automation and knowledgeable on GAMP5 and CFR21 part 11 compliance. Demonstrates a high level of Technical understanding with keen ability to trouble shoot technical issues. Ability to understand engineering processes through a logical, data driven, hands on approach. Experience in Cycle development and validation for sterile manufacturing. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2188 days ago