Full Job Description
Purpose of Job:
To provide technical and process-engineering leadership that drives continuous improvement in sterile manufacturing operations, ensuring compliance, efficiency, and product quality. This role will strengthen aseptic practices through training, coaching, and investigation support, while fostering a culture of operational excellence and risk reduction across Solutions operations.
Key Activities:
Provides process-engineering support for on-going Solutions operations to drive continuous improvements in quality, unit cost, and process efficiency.
Independently uses modern data analysis tools and process excellence (PE) methodologies to complete root cause analyses, identify corrective actions, and implement these actions into on-going production.
Understands and applies LEAN manufacturing techniques to drive process improvements.
Identifies, analyzes, and recommends opportunities to reduce compliance and aseptic risk.
Operates effectively and professionally with all required functions to support sterile manufacturing, including but not limited to operations, engineering, quality engineering, regulatory affairs, and program management.
Develops new systems to support on-going continuous improvements in processes, workflow, and documentation.
Provides technical direction and support as needed for all aseptic activities; skilled at supporting continuously operational processes on a 24/7 basis.
Leads the aseptic coach program, ensuring consistent application of aseptic techniques, mentoring of coaches, and alignment with site aseptic excellence strategy.
Leads and delivers technical training for operations and support teams to ensure compliance, consistency, and capability in aseptic practices and process execution.
Authors and supports technical investigations, including root cause analysis, corrective and preventive action (CAPA) development, and timely closure of quality records.
Scope of Position:
To provide technical and process-engineering leadership that drives continuous improvement in sterile manufacturing operations, ensuring compliance, efficiency, and product quality. This role will strengthen aseptic practices through training, coaching, and investigation support, while fostering a culture of operational excellence and risk reduction across Solutions operations.
Qualifications:
Education: 4-year science/technical degree required. Preferably in microbiology, or chemical engineering.
Experience: Minimum of 4 years of aseptic manufacturing experience demonstrating a progression of skills in data analysis and project scope.
Must have experience supporting a 7x24 operation. Process validation experience preferred.
A documented history of ongoing professional development desired. cGMP training required.
Must have experience working in a controlled environment.
This position may be available in the following location: Greenville, SC
Our Benefit Programs: Employee Benefits: Bausch + Lomb