|Job Type:||Full Time|
With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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!
The key responsibilities of this position are:
- Leadership of EMEA and APAC teams responsible for establishing, maintaining and implementing standards-based approach for content, execution and visualization of batch activities from lab to patient.
1. Responsible for leading a global group accountable for the development, implementation and operational support of manufacturing execution philosophy and associated standards and computerized systems for all batch processing activities from lab to patient.
2. Develops, implements, maintains and governs S95/S88 standards, libraries, interfaces and associated systems for activities associated with batch production, testing and release at both internal and external sites including master process data, recipe libraries, recipe management, process control and data historian.
3. Ensures real time data access and analysis that is rapidly deployable, scalable to ensure compliance of products with regulatory filings.
4. Develops and implements a comprehensive overall design for electronic batch records and automated batch record review by exception, suitable for implementation at multiple global sites.
- Bachelor of Science in an Engineering or other Science discipline, Computer Science, or Management Information Systems.
- 10+ years’ work experience, with at least 5 years’ experience in execution systems
- 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 (SCADA, MES, PAT, OSI Pi Data historian, etc.) 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
- A proven track record of influencing the industry on execution systems via publications and presentations is strongly preferred.
- Experience building, managing, and deploying high performing, innovative and transformational process automation /execution systems across a global organization.
- 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.
- Ability to work across a range of countries and cultures
Competencies: Proven leadership, organizational and interpersonal skills by demonstrating the following competencies at the enterprise level:
Customer Orientation (Internal/External):
Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.
Enterprise Results and Value Orientation:
Looks for outcomes that maximize the benefits for the enterprise, not just their department or function. Pursues value realization for the enterprise even if their function does not benefit.
Collaboration and Influencing:
Champions a culture of inclusiveness and teamwork.
Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.
Global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others, and adapts own strategy towards enterprise value.
Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.
Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.