Job Title: Manufacturing Process Specialist
Role Overview
* Deliver projects and initiatives within the scope of continuous improvement in thawing, formulation, filling, filter integrity testing, and wash/autoclave areas to support new product introductions and capacity expansion.
* Execute process engineering activities such as cycle development protocols, project improvements, deviations, problem solving, change controls, and schedule compliance to meet regulatory standards.
* Provide support for existing aseptic syringe filling lines, including debagger, Ebeam, delid, deline, isolator, and syringe filling machines with multi-filling technologies.
* Support commercial manufacturing through key performance metrics (SQDCI) delivery and participation in regulatory audits.
Key Responsibilities
1. Bachelor's degree in an engineering discipline.
2. Strong problem-solving skills and analytical thinking.
3. Excellent documentation and protocol generation skills.
4. Minimum 3 years' experience in a highly regulated GMP environment.
5. Experience in syringe filling is advantageous.
6. Ability to lead major investigations and troubleshoot complex issues.
7. Fill weight cycle development experience for filling machines.
8. New product introduction experience to sterile manufacturing environments.
What We Offer
* Opportunity to work on diverse projects and contribute to process improvements.
* Collaborative team environment with opportunities for professional growth.
* Challenging role that requires strong technical and problem-solving skills.