Production Owner

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

The Production Owner serves as the process subject matter expert, accountable for ensuring manufacturing processes are well-understood, controlled, documented, and executed in a consistent and compliant manner. The role focuses on identifying what is critical to the process, including critical quality attributes, process parameters, and regulatory commitments, to ensure reliable product quality and uninterrupted supply to patients.

This position monitors and analyzes process performance using data, ensures best-demonstrated methods are documented, standardized, and sustained, and collaborates cross-functionally with Manufacturing, Quality, and Engineering to maintain effective control strategies. The Production Owner supports continuous improvement, operator training and capability development, inspection readiness, and compliance with safety and regulatory requirements while fostering a culture of operational excellence aligned with CSL values.

Responsibilities:

Process Ownership & Expertise

• 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.

Process Monitoring & Performance Management

• 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.

Documentation Ownership & Standardization

• 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.

Control Strategy & Process Discipline

• 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

Continuous Improvement & Sustainability

• 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.

Regulatory & Inspection Support

• 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.

Safety & Compliance

• 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.

Qualifications:

Education

• Bachelor's degree in in Science or Engineering or equivalent degree may be considered dependent upon experience.

Experience

• 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.

Competencies

• Drives Results
• Manages Complexity
• Collaborates
• Communicates Effectively Optimizes Work Processes
• Operational & Manufacturing Acumen Change Management & Continuous Improvement
• Demonstrated experience analyzing complex data sets and reporting outcomes to multiple levels

The expected base salary range for this position at hiring is $101,000 - $120,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.