US Execution System Recipe Owner Bulk

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Owns the strategy and master plan for a recipe driven, fully integrated, and validated manufacturing facility across all CSL sites related to its value stream.

Must have strong leadership to ensure adherence globally as well as having technical and supervisory experience implementing manufacturing execution and process automation systems, including but not limited to, process control systems (PCS), manufacturing execution systems (MES), manufacturing data systems (historians, analytics), and PLCs. MES Scope includes full integration to ERP, QMS, Lab Systems, and Computerized Maintenance Management System (CMMS), resulting in a paperless manufacturing environment that enables batch review and release by exception.

Responsible for managing the ES staff across the different sites under his responsibilities (value stream and region). Allocates resources, assigns priority to tasks, provides guidance for design & troubleshooting to support the ES systems used for manufacturing operations & support. Manages the operating & capital budgets in support of Execution Systems. Assesses & develops new platforms for automated controls through Continuous Improvement & Operational Excellence initiatives.

This role is a member of the manufacturing SLT representing the execution systems team. They are the owner of the Execution System Cost Center.

Collaborate in the development and implementation of Execution System strategies and roadmap to design and implement the ES scope aligned with the global and standardized approach across the CSL network

• Accountable for System ownership and compliance of MES, PCS, PLC, Enterprise system interfaces, Data Historian, Building Management and Environmental Monitoring Systems
• Oversight & review of contractors/integrators work during design, construction, commissioning, and validation
• Manages the Execution Systems project scoping and site level OPEX & CAPEX budgets in collaboration with the Project Delivery group as applicable.
• Global Value Stream recipe owner & management of local site value stream.
• Foster a culture of innovation and big data by directly overseeing the execution of proof of concepts, pilots, and projects based on leading edge technology

Ensures alignment to standards and drives changes & improvements:

• Adhere to the Global Standards & Governance for Execution Systems to enable consistent implementation & operability across CSL sites and drive continuous improvement opportunities.
• Implement and maintain S95/S88 compliant systems for activities associated with batch production, testing and release including master process data, recipe libraries, recipe management, process control and data historian
• Lead the development and execution of Value Stream specific engineering documents including URS, Functional Specification, Design specifications, functional tests, Commissioning Plans, and Qualification Protocols. Other responsibilities include evolution of standards, procedures, training manuals, and other documentation for projects or internal use and providing training to operations and maintenance staff.
• Ensures real time data access and analysis that is rapidly deployable, scalable to ensure compliance of products with regulatory filings inclusive of a comprehensive overall design for electronic batch records and automated batch record review and release by exception
• Establish, report out, and continuously improve the automatic generation of KPI's within the ES organization to constantly review the organization effectiveness (ie: compliance, obsolescence, system availability and delivery)

Ensures sites have key Execution Systems partnership to support changes, issues & improvements

• Ensure all Sites experience Systems support predicated on a sense of urgency, consistent uptime & reliability, and strong customer focus
• Acts as the overall SME/POC for the global value stream owner, responsible for coordination of global alignment initiatives, changes, and process support for the assigned value stream.
• Accountable for leadership of Site ES PCS, MES, PLC and data system solutions and develops a sustainable support model that provides the appropriate service level to Manufacturing & other stakeholders to minimize manufacturing interruptions. Must also be familiar with and aware of the impact Laboratory Execution, ERP, Asset Management, and other Business Systems have on the operation of the plant.
• Works closely with Program/Project Management & stakeholders to effectively manage Execution System resources to deliver complex projects on time and on budget.
• Act as Safety and Quality Advocates, and supply resources for investigations
• Collaborate with Information and Technology initiatives & scope, including Infrastructure, Security, application, etc.

Lead site team of engineers responsible for the technical development, implementation and operational support of manufacturing execution philosophy and associated standards and computerized systems for all batch processing activities

• Responsible for hiring, coaching, mentoring and developing team members through conducting performance evaluations and development activities.
• Ensure regular training of personnel
• Constructively challenges direct reports and project teams to achieve goals and objectives.

Education:

• Bachelor of Science in an Engineering or other Science discipline/Masters preferred, Computer Science, or Management Information Systems.

Related Experience:

• 10+ 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.
• 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.