Job Description
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 conducing 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.
Current Contingent Workers apply
Not Applicable
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