Senior Aseptic Production Engineer & Asset Reliability Leader

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

Job summary

CSL Senior Production Engineer is a technical leader for aseptic fill/finish biotech operations in the United States. You will guide equipment reliability, oversee RCA and CAPAs, and ensure GMP-compliant engineering practices across asset lifecycle.

Responsibilities include developing preventive maintenance, analyzing SAP CMMS data, and mentoring junior engineers while driving continuous improvement in reliability and performance within the site’s ISO-aligned asset program.

Qualifications

• 5+ years engineering experience in aseptic fill/finish biotech or pharma manufacturing.
• 4+ years experience with isolator, vial washer, dehydrogenation tunnel, isolator, capper.
• Experience in aseptic processing and contamination control.
• Knowledge of Six Sigma/Lean principles is a plus.
• Experience supporting cGMP environments and regulatory inspections.

Responsibilities

• Provide senior-level frontline engineering support for complex equipment issues.
• Lead RCA using FMEA, 5-Why, Fishbone and ensure effective CAPA implementation.
• Develop preventive and predictive maintenance strategies based on asset criticality, historical performance, and condition monitoring data.
• Analyze asset health using CMMS data (SAP), including MTBF, MTTR, OEE contributors, and maintenance effectiveness KPIs.
• Champion predictive maintenance technologies and condition-based monitoring to reduce unplanned downtime and asset risk.
• Lead equipment-related changes through formal change control processes, ensuring GMP compliance and data integrity.

Skills

Technical problem-solving

Root cause analysis

Leadership

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering or related field

Tools

SAP CMMS

Job description

CSL Senior Production Engineer is a technical leader for aseptic fill/finish biotech operations in the United States. You will guide equipment reliability, oversee RCA and CAPAs, and ensure GMP-compliant engineering practices across asset lifecycle.

Responsibilities include developing preventive maintenance, analyzing SAP CMMS data, and mentoring junior engineers while driving continuous improvement in reliability and performance within the site’s ISO-aligned asset program.