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:
1. Participate in the planning, coordination, and implementation of next generation technologies being implemented in Batch and Continuous Manufacturing.
2. Transfer platform technologies from the earlier pipeline facilities and bringing to GMP status locally.
3. Transfer platform technologies to future commercial facilities.
4. 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.
5. Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.
6. Support troubleshooting and act as SME for manufacturing technology.
7. Aggregate process related knowledge and centralize for knowledge management.
8. Maintain GMP status of responsible equipment and areas by conducting routine monitoring, calibration, maintenance, certifications as needed.
9. Support the area’s implementation of process changes, and root cause investigation of deviations.
10. Support weekend or On Call duty on select times to support manufacturing during modern technology introduction.
11. Own life cycle development and qualification from initiation through implementation of methods / recipes for automated equipment, integrating into the overall site DeltaV System.
12. Active member of a cross-functional team managing both process and automation aspects of responsible unit operations.
13. Embody our Safety, Health and Environment guidelines and work towards company safety and environment goals.
What skills you will need:
1. Bachelor’s degree in Biology, Automation, Medical Device Technologies, or Process engineering.
2. Four to eight years of engineering experience.
3. Familiarity with Unit Operations for mAb manufacturing.
4. Competent in analyzing complex situations and show practical problem-solving capabilities.
5. Verbal or spoken communication skills in English.
6. Ability to work independently and within a cross-functional team.
Employee Status: Regular
Job Posting End Date: 02/14/2025
Requisition ID: R329787
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