Biologics Process Equipment Expert
We are seeking a highly skilled Biologics Process Equipment Specialist to join our team as a Subject Matter Expert for vial filling and isolator equipment, supporting pharmaceutical operations in the biotechnology and pharmaceutical industries.
Key Responsibilities:
* The SME will lead vial filling and isolator equipment activities from design to handover.
* Lead FAT and SAT activities to ensure equipment meets technical requirements.
* Develop commissioning plans and review validation protocols.
* Troubleshoot equipment malfunctions and support continuous improvement initiatives.
* Collaborate with internal and external teams to optimize equipment and process performance.
Requirements:
* Degree in Engineering, Science, or a technical discipline is required.
* A minimum of 5+ years of combined experience in Process, Equipment, or Manufacturing Engineering within a pharmaceutical or healthcare organization is essential.
* 3+ years of experience in a manufacturing environment (biotechnology, pharmaceutical, or healthcare) is necessary.
* Experience with biotechnological or parenteral drug manufacturing, solutions preparation, and sterilization is a plus.
* Familiarity with new product introductions to pharmaceutical facilities is desirable.