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Automation Lead, Fractionation
$138,000 - 164,000
CSL Behring
Ken Hayes Drive, Bradley
$138,000 - 164,000
Requirements
Must:
- Bachelor of Science in Engineering, Automation, Computer Science, or a related field.
- 5 to 10 years of experience in automation technologies within the pharmaceutical industry.
- Over 8 years of leadership experience in the pharmaceutical sector, including direct management in Manufacturing, Engineering, or Execution Systems/Automation.
- At least 5 years of experience in Execution Systems/Automation design and support.
- Proven track record in process automation and a solid understanding of MES and batch manufacturing industry standards (ISA S88 & S95).
- Hands-on experience in designing, implementing, and supporting automation and execution systems in regulated, large-scale process manufacturing.
- Experience with site-based shop floor systems across a globally distributed environment is highly desirable.
- Familiarity with project delivery through external providers and partners.
- Strong influence and communication skills, with the ability to convey ideas clearly at all organizational levels.
- Ability to cultivate, mentor, and develop a high-performing team.
- Knowledge of Process Excellence methodologies is beneficial but not mandatory.
- Functional understanding of cGMPs and operational processes in regulated facilities.
Responsibilities
- Manage the day-to-day automation responsibilities for the designated manufacturing value stream (e.g., PLC, PCS/DCS, MES, interfaces).
- Ensure optimal system availability, performance, and compliance to support continuous 24/7 manufacturing operations.
- Lead the troubleshooting efforts, change control processes, incident response, and root cause analysis for automation-related challenges.
- Oversee compliance with GAMP 5, GxP standards, data integrity, and site quality requirements.
- Work closely with Operations to reduce production impacts and enhance right-first-time performance.
- Act as the system owner for the value stream automation platforms as assigned by the Site Automation Head.
- Execute lifecycle management tasks, including updates, patch management, obsolescence handling, and routine evaluations.
- Collaborate with CSV and Quality teams to maintain systems in a validated state.
- Align with ISA-88/ISA-95 standards and local/global Operational Technology (OT) architecture guidelines.
- Support long-term planning for system sustainability and upgrades within the value stream.
- Maintain and manage recipes, phases, equipment modules, and MES master data for the assigned value stream.
- Lead initiatives to enhance batch performance, cycle duration, and equipment efficiency through automation improvements.
- Collaborate with Engineering and Operations to refine control strategies and batch processes.
- Ensure recipe adjustments comply with established change control and validation procedures.
- Track and analyze automation KPIs to spot potential improvements.
- Oversee the automation components of Tier 2/Tier 3 Operational Excellence and capital projects related to the value stream.
- Assist with design assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and hypercare processes.
- Ensure project adherence to global OT standards, cybersecurity protocols, and validation criteria.
- Coordinate with Engineering, Quality, Operations, and I&T during project execution.
- Manage small to medium-scale automation projects within the value stream.
- Serve as the primary point of contact for automation within the designated manufacturing value stream.
- Collaborate with Operations, Technical Operations, Quality, CSV, and local I&T departments.
- Provide support for audits, inspections, and regulatory engagements affecting the value stream.
- Communicate system statuses, risks, and enhancement plans to site leadership.
- Ensure alignment between local practices and enterprise automation standards.
Description
At CSL Behring, we are a leading global biotherapeutics organization committed to our mission of saving lives. We focus on fulfilling the needs of patients by leveraging the latest technologies to discover, develop, and deliver innovative therapies for individuals with critical conditions across multiple therapeutic areas. Our operations are underpinned by three key scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. We proudly operate one of the worlds largest plasma collection networks, CSL Plasma, and are part of a parent company that employs 32,000 individuals and provides lifesaving therapies to more than 100 countries. We champion an inclusive culture that values diversity and belonging, fostering a dynamic workplace where innovation thrives. For those who want to know more about our benefits and how we support our employees well-being, please visit our website.
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