Sterile Manufacturing Specialist
This role involves the delivery of projects under the bracket of continuous improvement in existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion.
The ideal candidate will have a degree in an Engineering discipline, strong problem-solving skills, and experience in syringe filling. They will also be able to lead major investigations, develop fill weight cycles for filling machines, and introduce new products to sterile manufacturing environments.
Key Responsibilities:
* Deliver projects that support NPI and capacity expansion.
* Execute process engineering activities to schedule and comply with safety standards.
* Provide support on existing aseptic syringe filling lines.
* Support commercial manufacturing through delivery of key performance metrics.
* Participate in regulatory audits.
Requirements:
* Degree in an Engineering discipline.
* Strong problem-solving skills.
* Experience in syringe filling (advantageous).
* Ability to lead major investigations.
* Familiarity with fill weight cycle development for filling machines.
* New product introduction experience to sterile manufacturing environments.