Director, Process Engineering Site Lead - US
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!
The process engineering site lead is accountable to lead the process engineering teams on site: supporting day-to-day business with process engineering and scientific knowledge and resources; focused on site execution and support; site point of contact for process engineering. S/He works closely with the Product, Process, Technology owners.
Kankakee role reports to: Global Head of Process Engineering
Reporting to this position
- Teams are comprised of engineers/scientists. Depending on site size, complexity & product diversity the team sizes would range from 10-20 people
Principal Accountabilities: Itemize the separate duties and responsibilities of the position. Fully detail each major task or responsibility necessary to correctly perform the position function. The tasks are ranked from those most crucial in the beginning of the section to those, which are more routine in the end of the section.
Drives changes & implements improvements through monitoring production activity and outputs in partnership with manufacturing, to affect the following:
- Real time process monitoring and data analysis trending in partnership with manufacturing
- Understands process variability and robustness on the floor to provide proactive and early observation of negative process trends and looks to eliminate or mitigate potential future performance challenges
- Understands and constantly tracks manufacturing and quality’s “day to day” challenges to ensure best support and allow improved performance anywhere in the production cycle from plasma to final product. Works to improve yield, increase process robustness, reduce costs, improve cycle times, improve throughput capacity, work toward zero deviation strategy
- Being the “eyes and ears” on the floor in routine production and engages Product/Process/Technology (PPT) owner support effectively
Deploys continuous improvement efforts from either internal identified needs or in implementing common or centralized process engineering improvement and modernization efforts
- Partners with R&D to develop and enhance “Quality by Design” (QbD) life cycle management. This includes efforts to document current processes, continuous improvement of the process, the maintenance of QbD tools with new knowledge, data and experiences generated in end-to-end operations
- Supports process engineering technology ownership – manages and retires, as needed
- Supports process improvement execution in partnership with and guided by Product/Process/Technology owner, Innovation & Modernization and R&D
- Identification and prioritization of potential improvements resulting out of routine manufacturing
- Strive for integration of full automation and technical industrial standards, such as Industry 4.0
Key process engineering partner on site to manage changes, issues & improvements
- Partners with Quality, Manufacturing & R&D to support process investigations such as root cause investigation
- Supports changes introduced through material science integration such as new filters, resins, raw materials. Supports second supplier strategy, vendor incoming material changes, global alcohol standard and other changes in partnership with PE material science group
- Supports on site tech transfer process and expansion
- Undergraduate degree in Engineering
- 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
- Ability to work across a range of countries and cultures
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.