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Process Engineering Lead, Drug Product External Manufacturing Operations
vor 2 Wochen
As a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and geographies, driving yield/performance improvements, supporting deviation investigations related to process robustness and associated corrective action/preventative action (CAPA). You will also ensure the application of engineering and scientific knowledge to support all DPs in routine operations at CMOs, primarily in Europe and sometimes North America.
This role requires significant international travel (40%).
Responsibilities:
- Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing
- Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained
- Ensure key process and asset attributes relevant to reducing variability are tracked, increasing performance of the process and visualizing in reporting
- Evaluate long-term trends, maintain log of loss drivers (e.g. performance, availability and quality losses), identify improvement levers, and plan robustness and continuous improvement initiatives
- Support deviations linked to process robustness, train and coach others on how to interpret robustness trends, actively liaise with other functions to identify loss drivers, including aseptic process/technology owner, QA specialist and broader Global Engineering
- Participate in cross-functional, external plant operations teams, act as single point of contact (SPOC) for Engineering in such teams, engage broader organization to drive problem solving capability and lead investigations through the use of problem-solving tools
- Provide technical person in plant (PIP) support for routine CMO operations as required and in conjunction with Quality PIP. Represent CSL Behring at technical interface with CMO partners
- The position doesn't include direct reports
Qualifications & Experience:
- University degree in engineering or science; higher degree preferred
- Aseptic/sterile processing and visual inspection of biopharmaceuticals in one or more of Operations, Process Engineering or Quality Assurance (9+ years post graduate experience)
- Fluency in German and English
- Experience in GMP, problem solving, continuous improvement, vendor relationships, data analysis & interpretation
Additional Comments:
This is a matrix leadership role working with internal and external partners to deliver reliable, efficient, on-time performance from the CMO network for DP manufacture. As such, the ability to work across national and cultural boundaries, honed analytical skills, detailed planning, and interpersonal savvy to achieve partner buy-in for strategies and plans will be essential for success. An ability to resolve routine issues at point whilst maintaining an acumen for stakeholder management and escalation of topics impacting product supply, multimillion dollar provisions or patient safety will also be required.
