Job Title: Process Development Specialist
The role of the Process Development Specialist involves working closely with cross-functional teams to develop and optimize single-use materials used in biologics manufacturing processes. This position requires a strong understanding of single-use technology, material science, and process development principles.
Responsibilities:
* Lead and/or assist risk assessments for the introduction or modification of single-use materials, including required change management activities.
* Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for single-use complaints.
* Assist with the development of manufacturing processes for new products, including developing and/or reviewing process-related documents.
* Prepare and update specifications related to NPI materials and consumables, including single-use materials used in the product path.
* Provide operational technical support for process-related issue resolution, design experiments to investigate new processes or failure modes, assist and/or lead single-use process-related investigations.
* Monitor and analyze process data during manufacturing.
* Support, supervise, and train operations personnel for SU processes.
* Adhere to and support all EHS&E standards, procedures, and policies.
Requirements:
* Degree in science, engineering, or other relevant technical subject area.
* 2+ years direct experience in the use of single-use materials for biologics manufacturing in GMP environments.
* 1+ years experience in the design, onboarding, and qualification of single-use assemblies for biologics manufacturing.
Why you should apply:
This is an excellent opportunity to join a world-class manufacturing operation with a strong culture of continuous improvement and innovation.
We are seeking a skilled Process Development Specialist to join our team, who can work collaboratively with global stakeholders to advance our goals.