Automation Value Stream Lead, Fractionation

The Automation Value Stream Lead - Fractionation is responsible for end-to-end automation performance and lifecycle management for the Fractionation manufacturing value stream at the site. Reporting to the Automation Site Head, this role ensures reliable, compliant, and efficient operation of process control systems, MES, and associated automation platforms supporting the production area.

The role provides technical leadership, operational support oversight, and project execution within the Fractionation value stream while ensuring alignment with site and global Engineering and Maintenance standards. Through close partnership with Operations, Engineering, Quality, and I&T, the Automation Value Stream Lead - Fractionation drives system reliability, continuous improvement, and digital readiness within the Fractionation manufacturing area.

Responsibilities:

1. Value Stream Automation Operations & Reliability

• Provide day-to-day automation ownership for the assigned manufacturing value stream (e.g., PLC, PCS/DCS, MES, interfaces).

• Ensure high system availability, performance, and compliance supporting 24/7 manufacturing operations.

• Lead troubleshooting, change control, incident response, and root cause investigations for automation-related issues.

• Ensure adherence to GAMP 5, GxP, data integrity, and site quality standards.

• Coordinate closely with Operations to minimize production impact and improve right-first-time performance.

2. System Ownership and Lifecycle Management (Value Stream Scope)

• Serve as system owner for value stream automation platforms as delegated by the Site Automation Head.

• Execute lifecycle management activities including upgrades, patching, obsolescence management, and periodic reviews.

• Maintain systems in a validated state in collaboration with CSV and Quality.

• Ensure alignment with ISA-88/ISA-95 models and site/global OT architecture standards.

• Support long-range planning for system sustainment and modernization within the value stream.

3. Recipe, Equipment, and Process Optimization

• Own and maintain recipes, phases, equipment modules, and MES master data for the assigned value stream.

• Drive continuous improvement of batch performance, cycle time, and equipment utilization through automation enhancements.

• Partner with Engineering and Operations to optimize control strategies and batch execution.

• Ensure recipe changes follow proper change control and validation processes.

• Monitor and trend automation KPIs to identify improvement opportunities.

4. Automation Project and Enhancement Delivery

• Lead automation scope for Tier 2/Tier 3 OpEx and capital projects within the value stream.

• Support design reviews, FAT/SAT, commissioning, and hypercare activities.

• Ensure projects comply with global OT standards, cybersecurity requirements, and validation expectations.

• Coordinate cross-functionally with Engineering, Quality, Operations, and I&T during project execution.

• Manage small to mid-size automation initiatives within the value stream.

5. Stakeholder Engagement and Cross-Functional Alignment

• Serve as the primary automation interface for the assigned manufacturing value stream.

• Partner closely with Operations, Technical Operations, Quality, CSV, and local I&T.

• Support audits, inspections, and regulatory interactions impacting the value stream.

• Communicate system status, risks, and improvement plans to site leadership.

• Ensure alignment between local execution and enterprise automation standards.

Education

• Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.

• 5–10 years of experience within automation technologies in the pharmaceutical industry.

Experience

• 8+ years' practical leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems/Automation; 5 years or more working experience in Execution Systems/Automation design and support

• Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95).

• Direct experience designing, building, deploying and supporting automation and execution systems in a regulated large-scale process-based manufacturing environment.

• Experience in running site-based shop floor systems in a globally distributed footprint is highly desirable.

• Experience in delivering projects via external providers and partners

• Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.

• Ability to build, mentor and grow a high performing and cohesive team.

• Experience in Process Excellence methodology is desirable but not required.

• Functional knowledge of cGMPs and manufacturing operations in regulated facilities.

Competencies

• Automation & Execution Systems Expertise

• Project Management

• Regulatory Compliance

• Team Leadership & Development

• Strategic Planning

• Continuous Improvement & Innovation

• Stakeholder Engagement

The expected base salary range for this position at hiring is $138,000 - $164,000. 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.

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.