Job Title: Single Use Process Specialist
The role of a Single Use Process Specialist is to work closely with site cross-functional teams and global science and quality teams on the development and evolution of single use materials used in biologics manufacturing processes.
This includes leading and/or assisting risk assessments for the introduction or modification of product path, including single use materials. It also involves interacting with manufacturers and vendors on best practices and validation packages, as well as functioning as technical lead for SU complaints.
Key responsibilities include preparing and updating specifications related to NPI materials and consumables, including single use materials used in the product path, and providing operational technical support for process-related issue resolution.
Additionally, this role involves monitoring and analyzing process data during manufacturing, supporting, supervising, and training operations personnel for SU processes, and adhering to and supporting 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 environment
• 1+ year experience in the design, onboarding, and qualification of single use assemblies for biologics manufacturing
• Experience in client-facing role collaborating with vendors and global stakeholders
Benefits:
• Opportunity to work with a state-of-the-art Biologics aseptic fill finish facility
• Collaborative and dynamic team environment
Other information:
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.