Process Engineering Lead, Drug Product External Manufacturing Operations

Job title: Process Engineering Lead, Drug Product External Manufacturing Operations

Company: CSL


Job description: 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.This role requires significant international travel.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 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 of pharmaceuticals in one or more of Operations, Process Engineering or Manufacturing Science & Technology (MSAT), (9+ years post graduate experience)
• Specific experience and knowledge with isolator technology (operations or engineering background), single-use-systems and filtration set-up, PUPSIT, manual, semi-automated and automated visual inspection. Deep knowledge of Annex 1 and experience in sterility assurance topics within operations/engineering
• Fluency in German and English.
• Experience in GMP, problem solving, continuous improvement, vendor relationships, data analysis & interpretation.
• Significant flexibility for international travel required (up to 40%).

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.Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about at CSL.About CSL BehringCSL 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 .We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL.Do work that matters at CSL Behring!

Expected salary:

Location: Bern

Job date: Fri, 14 Feb 2025 06:41:48 GMT

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