Process Engineering Specialist
The Process Engineering Specialist supports drug product fill-finish operations, new product introductions, and technical transfers within a GMP biologics facility.
* Perform gap analysis, facility fit studies, process safety assessments, and risk analyses for new product introductions to ensure manufacturing excellence.
* Monitor and analyze process data during manufacturing to identify trends and optimize production processes.
* Assist in the development and optimization of manufacturing processes for new and existing products, ensuring compliance with regulatory requirements.
Key Responsibilities:
* Develop, update, and maintain specifications, protocols, procedures, transfer plans, and manufacturing batch records related to NPI activities.
* Provide operational technical support, including troubleshooting during drug product fill-finish operations, to ensure seamless production.
* Lead and/or assist risk assessments such as PFMEA and EHS evaluations to mitigate potential risks.
* Support cross-functional teams and cost-improvement initiatives, providing technical expertise to daily operations and driving business results.
Requirements:
* A third-level degree in a relevant engineering, science, or technical discipline is required.
* Strong technical and operational knowledge of unit operations in a fill-finish facility is essential.
* Proven problem-solving skills, innovative thinking, strong attention to detail, and a commitment to quality are necessary for success in this role.
* Strong communication and interpersonal skills with the ability to influence and lead cross-functional activities are critical.