The Senior Director, Process Engineering 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 engineering, focused on process, system and technologies. S(he) is accountable for execution of all verification/commissioning, qualification and validation deliverables, Process technology engineering and Manufacturing Science and Technology aspects. This role leads managers with site teams comprised of engineers, scientists, and project managers. Supports and understands all end-to-end functions, networks and needs from a manufacturing site perspective and coordinates global function integration on site
Accountability (direct reporting) of all PE site functions in the space of Process, System and Technologies à Manufacturing Science and Technology, Process Technology, Validation, TT representation and C&Q (in house and external contracts)
SPOC person representing all engineering function in the space of day to day operations and supports the site and global project execution.
Responsible for development of PE managers and staff, including motivating in a manner that promotes the achievement of CSL’s business goals and objectives.
Establish performance goals and strategic/operational objectives for department.
Coach, counsel, and appraise performance of personnel.
Develop staff competencies & capabilities to enable sustained success and career development.
Promotes high employee engagement and a positive work environment.
Responsible for organizational design, budget resource requirements and staffing decisions.
Drives changes & implements improvements through monitoring production activity and outputs in partnership with manufacturing, to effect 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 process, system and technology SME and owner “eyes and ears” on the floor in routine production and engages global PE and engineering function effectively
- Deliver and execute, Validation, C&Q and TT on site for the customers Operations/VS and projects
Deploys continuous improvement efforts from either internal identified needs or in implementing common or centralized process engineering improvement and modernization efforts
- Partners with COE TT/LCM 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
- Drives process engineering technology ownership – manages and retires, as needed on site (following global standards)
- Execute process improvement in the sites in partnership with global PE and engineering functions
- 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 run process investigations such as root cause investigation. Focus on deviation prediction, prevention an continuous improvement in the space of Investigation and CAPA.
- 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
As the site representative of PE functions, this role will be accountable for successful site implementation of global best practices, policies, and framework developed and by the Global Engineering organization.
- Accountable to participate with other site leaders and centers of excellence supporting global initiatives toward harmonization and knowledge management efforts.
- Drive development of site-specific procedures that enable the implementation of global policies and standards.
- Ensure site projects are properly resourced and controlled for successful completion on time, within budget, and in alignment with global requirements and site needs. Lead and direct project management staff responsible for integrated planning and timelines across multiple projects requiring tech transfer, verification/commissioning, qualification and validation activities, as well as process science and technology deliveries. This includes management and negotiation of cross-functional dependencies and interactions.
- Develop a high-performing team of skilled PE all aspects practitioners who will execute projects in alignment with global network strategies and according to policies and practices developed by global centers of excellence.
- Provide leadership and direction for implementing new standards, cultural change and harmonization with site PE functions and their stakeholders.
- Support evaluation of site capabilities for evaluation of the CSL global network for process and method transfer site decisions.
- Represent PE function for site inspection readiness, execution, and responses. Coordinate the support of PE global and site-based SMEs as needed.
- Lead and direct staff providing PE expertise for issue resolution to support deviations or CAPAs and audit findings.
Undergraduate/Graduate degree in Engineering
- 10+ years or more working in Process Engineering or commercialization of biopharmaceutical products and processes in Pharmaceutical, Chemical Manufacturing or similar industry.
- 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 a multi-layered department across multiple technical specialties.
- 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
- Must have a strong understanding of biopharmaceutical operations and relevant GMP regulations and regulatory guidance
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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