Manufacturing Process Owner – Quality & CI Leader

CSL; Kankakee (IL); On-site; USD 101,000 - 120,000; Full time

Job summary

CSL Behring is seeking a Production Owner to serve as the process SME for key manufacturing processes, ensuring CQAs and CPPs are understood and controlled. You will document, standardize, and maintain process controls to deliver consistent product quality and uninterrupted supply to patients.

The role collaborates with Manufacturing, Quality, and Engineering to sustain control strategies, support CI and training, and prepare for inspections.

Qualifications

• 3+ years in pharmaceutical or biotech manufacturing.
• Experience with regulatory inspections and compliance.
• Audit and Investigation Skills, Report Writing Skills.
• Strong verbal, technical writing and interpersonal skills are required.
• Lean six sigma or equivalent certifications a plus.

Responsibilities

• Serve as the process subject matter expert (SME) for assigned manufacturing processes.
• Demonstrate deep understanding of critical quality attributes (CQAs), critical process parameters (CPPs), and process elements tied to regulatory filings.
• Understand what aspects of process outputs are critical to internal customers and downstream operations.
• Monitor process performance using data, including key input, process, and output measures.
• Review data collected by operators and summarize performance into dashboards and visual management tools.
• Ensure process performance data is charted, posted, and routinely reviewed in the work area.
• Ensure the manufacturing process is fully documented, used as written, and routinely updated.
• Own and maintain SOPs and batch records for process operations.
• Champion identification and implementation of best-demonstrated process methods, with emphasis on standardizing critical steps to protect quality and ensure reliable supply.
• Update process documentation promptly when changes occur and ensure it is consistently referenced during execution.
• Collaborate with Manufacturing, Quality, and Facilities & Engineering (local and global) to ensure an effective process control plan is established and maintained.
• Ensure operators understand: How the process should operate; How to detect early signs of disturbance or failure; What actions to take per defined response plans.
• Ensure improvements identified through CI projects, investigations, or initiatives are embedded, documented, and sustained in the process.
• Identify opportunities to reduce variability, waste, and non-value-added activities. Collaborate with CI Specialists to elevate identified areas for improvement.
• Support implementation of improvements that enhance safety, quality, efficiency, and supply reliability.
• Act as Process SME during internal and external regulatory inspections and audits.
• Clearly explain process design, controls, documentation, and performance history to auditors and regulators.
• Comply with CSL Behring's Safety Program, Health and Safety mandates, and OSHA requirements.
• Ensure safety considerations are integrated into process execution, standardization, and improvement activities.

Skills

Regulatory Inspections

Audit & Investigation

Documentation & SOPs

Cross-functional Collaboration

Education

Bachelor's degree in Science or Engineering

Job description

CSL Behring is seeking a Production Owner to serve as the process SME for key manufacturing processes, ensuring CQAs and CPPs are understood and controlled. You will document, standardize, and maintain process controls to deliver consistent product quality and uninterrupted supply to patients.

The role collaborates with Manufacturing, Quality, and Engineering to sustain control strategies, support CI and training, and prepare for inspections.