Quality Validation Project Lead – GMP Commissioning

CSL Plasma; Kankakee (IL); On-site; USD 91,000 - 120,000; Full time

Job summary

CSL Behring in Kankakee is expanding Ig production facilities and seeks a Quality Oversight lead for C&Q activities. You will ensure GMP-compliant validation planning, review SOPs, and support regulatory inspections while collaborating with Project Quality, KAN Site Quality, and Global Engineering across sites.

The role requires ~5 years of GMP quality experience, strong regulatory knowledge (FDA/EU), and expertise in commissioning/qualification of production facilities and cleanrooms.

Qualifications

• 5 years' quality/GMP experience in pharma/biotech.
• Experience with FDA, TGA, EU regulatory guidelines.
• Experience in commissioning and qualification of facilities and cleanrooms.

Responsibilities

• Ensure GMP-compliant validation planning and execution.
• Maintain quality systems and SOPs for cGMP compliance.
• Support audits and regulatory inspections.
• Provide quality oversight of commissioning and qualification activities.
• Collaborate cross-functionally with Project Quality and Global Engineering.

Skills

Fluent English

Quality processes

Communication

Risk-based decisions

Education

Degree in relevant scientific discipline

Job description

CSL Behring in Kankakee is expanding Ig production facilities and seeks a Quality Oversight lead for C&Q activities. You will ensure GMP-compliant validation planning, review SOPs, and support regulatory inspections while collaborating with Project Quality, KAN Site Quality, and Global Engineering across sites.

The role requires ~5 years of GMP quality experience, strong regulatory knowledge (FDA/EU), and expertise in commissioning/qualification of production facilities and cleanrooms.