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


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Lead Engineer in Manufacturing Science

vor 3 Monaten


Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

Position Overview
The Manufacturing Science & Technology (MS&T) Site Lead plays a pivotal role in shaping the strategy and providing technical guidance for the Site's Manufacturing Value Streams, which include Base Fractionation, Bulk Production, Aseptic Filling, and Visual Inspection. This position is crucial for ensuring safety, quality, and reliability across a diverse array of complex 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 broad collaborative network to facilitate ongoing technical support for manufacturing challenges and enhancements.
  • Collaborate with global Centers of Excellence, Process Owners, and Product Technical Stewards to enhance 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, ensuring effectiveness checks are in place.
  • Conduct technical assessments for deviations, providing justifications, investigations, and determining corrective and preventive actions (CAPAs).
  • Lead site and global taskforces to address critical and complex deviations and issues.
  • Possess a deep understanding of regulatory requirements, working closely with Manufacturing Value Streams, Quality, and Regulatory Affairs to develop efficient compliance strategies.
  • Oversee technical aspects of site regulatory submissions, ensuring readiness for inspections and addressing findings.
  • Facilitate high-level discussions and debates, guiding stakeholders towards consensus on strategic and policy matters.

Qualifications

  • Undergraduate or graduate degree in Engineering or a related technical discipline.
  • Over 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 deploying best practice frameworks, processes, tools, and templates.
  • At least 5 years of experience in a global matrix organization.
  • Experience working in cross-functional, multicultural, and international teams.
  • Strong understanding of biopharmaceutical operations and relevant GMP regulations and guidance.

What We Offer

  • Competitive salary and comprehensive benefits package.
  • Additional leave days dedicated to personal well-being.
  • Family services including psychological support, legal advice, and family care services.
  • 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 innovative treatments provide hope to patients in over 100 countries, addressing conditions in various therapeutic areas including immunology, hematology, cardiovascular, metabolic, respiratory, and transplant. We are committed to fostering a diverse and inclusive workplace that reflects the global community we serve.