Provides technical support to engineers and scientists in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations.
The Process Owner will collaborate with Manufacturing, Quality, and Facilities & Engineering to ensure it continues to meet internal customer, business, and patient needs. The primary aim of the role is to lead key process transformation, design and improvement efforts. The Process Owner will lead a mix of strategic and tactical assignments of various complexities each with an opportunity to achieve measurable results. The incumbent will exhibit knowledge and provide coaching/training to colleagues while leading process and quality initiatives, as necessary.
Demonstrated ability to understand what is critical about the process.
Recognizes what are the critical quality attributes and process parameters.
Understands what about the output is important to internal customers of the process.
Ability to identify what about the process is tied to the regulatory filings.
Monitors process performance with data by including both input/process parameters and output measures. Monitor data compiled by process operators and summarize into a dashboard.
Ensures the process is documented, and that the documentation is used and updated routinely .
Championing efforts to identify the best-demonstrated process methods, particularly what parts of the process must be standardized so that output quality and reliable supply to patients do not suffer.
Documenting the best-demonstrated methods and ensures they are referenced constantly. Updates the documentation for the process when it changes.
Owns the SOP and batch records for process operation.
Closely collaborates with internal and global functions (Manufacturing, Quality, and Facilities & Engineering) to ensure a control plan is in place.
Ensures everyone in the work area knows how the process should operate.
Assurances everyone knows how to detect signs of trouble and what to do if a problem appears (response plan).
Confirms process data is charted and posted in the work area.
Ensures that any improvements identified through projects are incorporated and maintained in the process.
Act as Process SME during internal and/or external Regulatory inspections.
Provides necessary training and resources for the process operators to do their jobs well and keep getting better. Resources may include appropriate training, materials, information, and equipment.
Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
Completes any other duties/responsibilities assigned by senior management.
• Bachelor degree or equivalent, or equivalent vocational or technical education
• 5+ years' experience
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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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.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!