Process Engineer II, III

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

This position will be for a M-F ~8am-5pm Position supporting the Filling area. This position requires on site work in Holly Springs, NC and will involve supporting an on-call rotation. The position will report to the Sr. Manager Processing Engineering Fill Finish and work to support operations and equipment in the area.

Responsibilities:

• Works independently with general supervision in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects
• Manages from concept and scoping phase, design, preparation of specifications, appropriation requests, through to procurement, installation and start up phases for capital, expense and lease additions to a facility
• Assures compliance with FDA, EPA, and OSHA requirements during all phases of assigned projects
• System ownership of PFS high speed filling line,
• Support deviation investigations and interface with equipment owners and stakeholders
• Owns Actions in Trackwise change management system
• Maintains Documents in Veeva GDocP System
  

Qualifications:

• MS/MBA/BS/BA in Engineering, Business Administration or Life Sciences preferred
• 3+ years practical experience in pharmaceutical industry in Manufacturing, Engineering or Quality Assurance
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
• Understanding of project management principles and project lifecycle phases. Knowledge of Validation, CMC and facility regulatory submission requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.