Job Description
An amazing opportunity has arisen for an Engineering Specialist in our state-of-the-art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
Bring energy, knowledge, innovation, and leadership to carry out the following:
* Participate in the planning, coordination, and implementation of next generation technologies being implemented in Batch and Continuous Manufacturing.
* Transfer platform technologies from the earlier pipeline facilities and bringing to GMP status locally.
* Transfer platform technologies to future commercial facilities.
* Partner within a cross-functional team to implement modern technologies / software / instruments that can simplify and reduce effort around manufacturing and administrative processes, sharing with network counterparts.
* Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.
* Support troubleshooting and act as SME for manufacturing technology.
* Aggregate process related knowledge and centralize for knowledge management.
* Maintain GMP status of responsible equipment and areas by conducting routine monitoring, calibration, maintenance, certifications as needed.
* Support the area’s implementation of process changes, and root cause investigation of deviations.
* Support weekend or On Call duty on select times to support manufacturing during modern technology introduction.
* Own life cycle development and qualification from initiation through implementation of methods / recipes for automated equipment, integrating into the overall site DeltaV System.
* Active member of a cross-functional team managing both process and automation aspects of responsible unit operations.
* Embody our Safety, Health and Environment guidelines and work towards company safety and environment goals.
What skills you will need:
* Bachelor’s degree in Biology, Automation, Medical Device Technologies, or Process engineering.
* Four to eight years of engineering experience.
* Familiarity with Unit Operations for mAb manufacturing.
* Competent in analyzing complex situations and show practical problem-solving capabilities.
* Verbal or spoken communication skills in English.
* Ability to work independently and within a cross-functional team.
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