Production Owner
CSL
Summary
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.
Job description
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 escalate 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 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
Requirements
- Bachelor's degree in Science or Engineering or equivalent degree may be considered dependent upon 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.
Benefits
- Incentive compensation
- Equity
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.