Job Description
As a key member of our Engineering team, you will be responsible for serving as a Subject Matter Expert (SME) for vial filling and isolator equipment in our pharmaceutical operations.
Key responsibilities include:
* Acting as the SME for vial filling and isolator equipment from design to handover.
* Leading FAT and SAT activities to ensure equipment meets technical requirements.
* Developing and executing commissioning plans and reviewing validation protocols.
* Troubleshooting equipment malfunctions and supporting continuous improvement initiatives.
* Collaborating with internal and external teams to optimize equipment and process performance.
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Required Skills and Qualifications
To succeed in this role, you will need to possess the following qualifications:
Education: Degree in Engineering, Science, or a technical discipline.
Experience: 5+ years combined experience in Process, Equipment, or Manufacturing Engineering within a pharmaceutical or healthcare organization. 3+ years in a manufacturing environment (biotechnology, pharmaceutical, or healthcare).
Preferred Skills: Experience with biotechnological or parenteral drug manufacturing, solutions preparation, and sterilization. Familiarity with new product introductions to pharmaceutical facilities.