Director, Process Engineering Process Fractionation

With operations in 35+ nations and ~ 20,000 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 operatesCSL 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!

Responsibilities

The Process Owner role is responsible to plan and implement continuous improvements, innovation initiatives as the end-to-end technical process owner for the Purification area. S/He will oversee the process knowledge resources and expertise for Purification area within end-to-end operations and be a key contact internally.

This role will have a wide focus including understanding process yield, robustness tracking & improvement and processing cost reduction and improvement. Additional focus will be to assess fit, operationalize continuous improvement or modernization efforts, and drive standardization in the technical process, as appropriate.

Qualifications

• Supports manufacturing and site PE teams to develop KPI performance monitoring and tracking mechanisms for Fractionation. This includes process real time monitoring: definition, integration and update of business drivers and “quality by design” (QbD) identified process performance indicator such as critical process parameters.
• Responsible for process engineering as the Purification process owner to operationalize expansions, tech transfers and quality by design initiatives. This includes defining user requirement specifications, subject matter expert participation on the task force for major process deviations or challenges during tech transfer and validation and key contributor in the process risk analysis.
• Develops plans for KPI measures on process performance internally and benchmarks to best practices externally. Implements process improvements as an output of operational improvements or innovation and modernization initiatives.
• Evaluates new processes; capability, robustness, scalability, “manufacturing fit” in partnership with the process engineering product & technology owners and R&D. Implements the technical mid and long-term process improvement strategy into sites with the local site teams. Drives technical process standardization and harmonization
• Drives constant improvement of process understanding, including multiple process parameter interaction and impact on protein precipitation and separation in partnership with R&D
• Responsible for creating and updating process user requirement specifications – supporting technology transfer and expansions. Supports outsourcing strategies and initiatives such as external filling, packaging and labeling as technical process subject matter expert

Education:

• Undergraduate degree in Engineering or other relevant technical field.

Related Experience:

• 8+ years or more working in Process Engineering in Pharmaceutical, Chemical Manufacturing or similar industry. 5 years or more working experience in the pharmaceutical industry preferred
• Demonstrated experience in process improvement development & execution
• Strong communication and conflict management skills to influence project professionals and stakeholders, including non‐specialists, at all levels in the organization
• Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates in an Operations context, in alignment with Enterprise standards
• 5 years or more experience working within a global matrix organization
• Involvement in cross-functional, multicultural and international teams

Special Training:

• 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.

Excellent technical judgement and functional skills:

Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.

Problem Solving, Creativity and innovation management:

Uses rigorous logic and methods to solve difficult problems with effective solutions, can see hidden problems, is excellent at honest analysis.

Interpersonal Savvy:

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.

Capabilities

Worker Type:

Employee

Worker Sub Type:

Regular