Manufacturing Specialist I/II

KBI Biopharma • Durham, NC

1d

About The Position

The Associate Manufacturing Specialist/Manufacturing Specialist I, II, III/Sr. Manufacturing Specialist, Manufacturing Technical Support and Investigations (Manufacturing Specialist) is responsible for supporting equipment and cGMP operations for the upstream, downstream, and/or manufacturing support teams in a large-scale biopharmaceutical facility. The Manufacturing Specialist has experience in upstream unit operations (seed expansion, bioreactor operations, cell culture harvest) or downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and a working knowledge of upstream equipment or downstream equipment, as well as general bioprocessing equipment and disposable technologies. The Manufacturing Specialist possesses proven technical writing and problem-solving skills and a drive for continuous improvement. From a technical perspective, the Manufacturing Specialist is responsible for system ownership activities such as generating manufacturing procedures and records, procuring and enrolling manufacturing equipment, defining equipment maintenance requirements, supporting equipment commissioning and qualification activities, driving operational excellence initiatives, and performing other activities required of system owners. From a compliance perspective, the Manufacturing Specialist is responsible for performing thorough and robust manufacturing investigations, implementing effective corrective/preventative actions, and managing manufacturing change controls. The Manufacturing Specialist is responsible for working cross-functionally with the manufacturing departments, QA, MS&T, engineering, supply chain, IT, AFS and other key departments to ensure manufacturing operations are successful, reliable, and compliant. Senior specialists shall demonstrate subject matter expertise and lead cross functional teams and large projects.

Requirements

• B.A./B.S. in a Life Sciences or Engineering degree and 0+ years relevant experience or equivalent education and experience.
• B.A./B.S. in a Life Sciences or Engineering degree and 2+ years relevant experience or equivalent education and experience.
• B.A./B.S. in a Life Sciences or Engineering degree and 4+ years relevant experience or equivalent education and experience.
• B.A./B.S. in a Life Sciences or Engineering degree and 7+ years relevant experience or equivalent education and experience.
• B.A./B.S. in a Life Sciences or Engineering degree and 9+ years relevant experience or equivalent education and experience

Responsibilities

• Generate and revise manufacturing documents such as electronic manufacturing records, logbooks, process flow charts, risk assessments, and equipment and facility procedures for specific manufacturing process units.
• Manage manufacturing materials and equipment: Design and enroll manufacturing assemblies, enroll and set-up new equipment, support equipment maintenance, execute commissioning/qualification activities, perform change control assessments, ensure appropriate equipment maintenance, and perform vendor coordination.
• Perform manufacturing investigations, problem solving, root cause analysis. Implement process improvements, CAPAs, Change Controls, and safety improvements.
• Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level