Fill-Finish Process Engineer II/III – On Site

CSL Vifor; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

CSL Vifor in Holly Springs, NC, seeks a process engineering professional to support the Fill Finish area on a M-F 8am-5pm schedule with on-site work and an on-call rotation. You will report to the Sr.

Manager Processing Engineering Fill Finish and collaborate with operations and equipment teams. Responsibilities include leading process improvement projects, from concept to startup, ensuring cGMP and regulatory compliance, and owning Trackwise change actions while maintaining Veeva GDocP

Qualifications

• Bachelor's or higher in Engineering, Life Sciences, or related field.
• Minimum 3 years in pharmaceutical manufacturing, engineering, or QA.
• Solid knowledge of cGMPs and FDA-regulated operations.
• Familiarity with project lifecycle, validation, and regulatory submissions.

Responsibilities

• Lead process-related improvement projects with safety and regulatory compliance.
• Oversee capital, expense and lease additions from concept to startup.
• Ensure FDA/EPA/OSHA compliance in all phases.
• Own Trackwise change management actions and deviations.
• Maintain documents in Veeva GDocP system.

Skills

Process engineering

Project management

cGMPs knowledge

Regulatory compliance

FDA/regulatory awareness

Education

MS/MBA/BS/BA in Engineering, Life Sciences or related field

Tools

Trackwise

Veeva GDocP

Job description

CSL Vifor in Holly Springs, NC, seeks a process engineering professional to support the Fill Finish area on a M-F 8am-5pm schedule with on-site work and an on-call rotation. You will report to the Sr.

Manager Processing Engineering Fill Finish and collaborate with operations and equipment teams. Responsibilities include leading process improvement projects, from concept to startup, ensuring cGMP and regulatory compliance, and owning Trackwise change actions while maintaining Veeva GDocP