Aktuelle Jobs im Zusammenhang mit Lead Engineer in Manufacturing Science - Marburg an der Lahn, Hessen - CSL Behring

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    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring GmbH Vollzeit

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Lead Engineer in Manufacturing Science

vor 3 Monaten

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

Position Overview
We are seeking a Manufacturing Science & Technology (MS&T) Site Lead to oversee our Process Engineering division. This role is pivotal in shaping the strategy and providing technical leadership to enhance the Site's Manufacturing Value Streams, including Base Fractionation, Bulk Production, Aseptic Filling, and Visual Inspection. The successful candidate will have a direct influence on safety, quality, and supply reliability across a variety of intricate processes and products.

Key Responsibilities
  • Act as the primary technical liaison for the Site's Manufacturing Operations across all Value Streams and Facilities.
  • Establish and nurture a diverse collaborative network to ensure ongoing technical support for manufacturing challenges and enhancements.
  • Collaborate with global Centers of Excellence, Process Owners, and Product Technical Stewards to bolster Process Robustness through effective monitoring, Quality by Design (QbD) lifecycle management, and standardization of global processes and technologies.
  • Provide leadership in technical design, risk management, and the implementation of changes while ensuring their effectiveness.
  • Conduct technical assessments of deviations, including justification, investigation, and the formulation of corrective and preventive actions (CAPAs).
  • Lead site and global Taskforces to address critical and complex deviations and challenges.
  • Comprehend regulatory requirements and work with Manufacturing Value Streams, Quality, and Regulatory Affairs to devise efficient strategies for compliance.
  • Oversee technical aspects of site regulatory submissions, ensuring readiness for inspections and addressing findings.
  • Facilitate high-level discussions and negotiations to guide stakeholders towards consensus on strategic and policy matters.
Qualifications
  • Bachelor's or Master's degree in Engineering or a related technical discipline.
  • A minimum of 10 years of experience in Process Engineering or the commercialization of biopharmaceutical products and processes within the Pharmaceutical or Chemical Manufacturing sectors.
  • Proven track record in process monitoring, analytics, and the development and execution of improvements.
  • Exceptional communication, negotiation, and conflict resolution skills to influence technical experts and stakeholders at all organizational levels.
  • Experience in managing and implementing best practice frameworks, processes, tools, and templates.
  • At least 5 years of experience working within a global matrix organization.
  • Experience in cross-functional, multicultural, and international team environments.
  • In-depth understanding of biopharmaceutical operations and relevant GMP regulations and guidance.
Benefits
  • Competitive salary and comprehensive benefits package.
  • Additional leave days to support personal well-being.
  • Access to family services, including psychological support and legal advice.
  • Flexible hybrid working arrangements.

About CSL Behring
CSL Behring is a global leader in the development and delivery of high-quality medicines for individuals with rare and serious diseases. Our therapies provide hope for patients in over 100 countries, addressing conditions in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas. We are committed to fostering a diverse and inclusive workplace that reflects the global community we serve.