Senior Aseptic Equipment & Reliability Engineer

CSL; Bradley (IL); On-site; USD 108,000 - 128,000; Full time

Job summary

CSL Vifor is seeking a Senior Production Engineer to provide technical leadership for aseptic filling operations and oversee asset reliability across the lifecycle. You will lead structured troubleshooting, RCA and CAPA, and drive maintenance and change management in a GMP environment.

The role requires extensive experience in aseptic fill/finish manufacturing, isolator systems, and related equipment, with a focus on reducing downtime and optimizing performance.

Qualifications

• Bachelor’s degree in Engineering required or equivalent.
• 5+ years of aseptic fill/finish pharma manufacturing experience.
• 4+ years with isolator systems, vial washer, depyrogenation tunnel, or related equipment.

Responsibilities

• Provide senior engineering support for complex equipment issues and lead structured troubleshooting.
• Drive maintenance strategies based on asset criticality and condition data (CMMS/SAP).
• LeadChange control processes for GMP-compliant engineering changes and CAPAs.
• Own asset information across lifecycle per ISO 55000, including URS, FS/DS, P&IDs and SAP CMMS records.
• Lead equipment-related CapEx/OpEx projects and oversee shutdowns.
• Support qualification/validation activities (IQ/OQ/PQ) and audits.
• Mentor engineers and technicians in reliability engineering and GMP practices.

Skills

Aseptic manufacturing

Root cause analysis

Project leadership

CAPA & GMP knowledge

Six Sigma

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

SAP CMMS

FMEA / RCA tools

Job description

CSL Vifor is seeking a Senior Production Engineer to provide technical leadership for aseptic filling operations and oversee asset reliability across the lifecycle. You will lead structured troubleshooting, RCA and CAPA, and drive maintenance and change management in a GMP environment.

The role requires extensive experience in aseptic fill/finish manufacturing, isolator systems, and related equipment, with a focus on reducing downtime and optimizing performance.