Equipment Process Engineer (Aseptic Sterile Fill Finish)
Asset Recruitment is currently recruiting for Equipment Process Engineers (Aseptic Sterile Fill Finish) the successful candidates will be based onsite at a multinational Biopharmaceutical facility in Carlow, Ireland. These roles will be for initial 12 month contract duration.
* Defining and reviewing equipment specifications and associated test documentation
* Troubleshooting equipment with particular emphasis on process cycles - cleaning, sterilizing, containment
* Maintenance of process cleaning and sterilization cycles for new product introductions
* Strong focus on disciplined Root cause analysis
* Coordinate the training of engineering/operations personnel on all technology and process, ensuring cGMP compliance.
* Setup and maintain manufacturing area equipment in compliance with the calibration and maintenance programs
* Participate in the internal EHS and Quality audits
* Lead engineering start up activities and new product introduction
* Degree in Chemical or Process Engineering or equivalent
* Postgraduate Qualification in Engineering or Science discipline advantageous
* Qualification in Project Management advantageous
* Min 5 years’ work experience in a Biologics or GMP environment as part of an Engineering, Technical Services or operations function ideally with Fill Finish Operations, Biologics Systems and Process knowledge.
* Execution of CQV of Process Equipment (e.g. Bioreactors / Process Vessels, Chromatography, Ultrafiltration, Autoclaves, Parts Washers).
* Knowledge and experience with Facility Start-Up Projects (brown field or green field).
* Equipment Vendor Package Ownership and System Design Coordination
* Technical Knowledge of process monitoring systems, automation systems (DeltaV), Operational Intelligence & Data Systems (Pi System) within a GMP manufacturing environment - beneficial and desirable but not a necessity.
* Qualification of GMP Utilities, Systems and Processes - WFI, Clean Steam, CIP, SIP.
* CQV of Lyophilisation equipment
* Troubleshooting and Providing Technical and Engineering Solutions for GMP Manufacturing Operations and Equipment in a Biologics Processing Environment.
* Full proficiency in automation and knowledge of GAMP5 and CFR21 part 11 compliance
* Cycle development and validation for sterile manufacturing
* Ability to understand engineering processes through a logical, data driven hands on approach