Beschreibung

For Lonza AG in Visp, Switzerland, we are looking for a Project Manager to lead the integration of capital expenditures (CapEx) and operational improvements (OpEx) in a mammalian commercial production line within a biopharmaceutical environment.

This position focuses on ensuring seamless coordination between the engineering, procurement, and construction management (EPCM) contractor and internal production staff to deliver a compliant, efficient, and successful project.

The role requires a professional with strong project management skills, a deep understanding of GMP compliance, and expertise in biopharmaceutical manufacturing processes. The ideal candidate will effectively bridge CapEx mechanical adaptations and OpEx operational enhancements, ensuring alignment, efficiency, and compliance throughout the project lifecycle.

Key Responsibilities

• Project Integration and Planning
  
• Act as the primary point of accountability for the overall project, ensuring alignment between EPCM activities and production team initiatives.
  
• Develop and manage a comprehensive project plan, integrating timelines, deliverables, and milestones for both mechanical adaptations and operational improvements.
  
• Coordinate cross-functional teams, including engineering, production, quality assurance, and validation, ensuring smooth communication and collaboration.
  
• Establish clear roles and responsibilities for all stakeholders, ensuring a unified approach toward achieving project objectives.
  
• Stakeholder Coordination
  
• Serve as the central point of contact between EPCM, Engineering Project Manager, production staff, and other stakeholders to ensure seamless communication and collaboration.
  
• Align project goals and deliverables with cross-functional teams, including engineering, quality assurance, and manufacturing.
  
• Change Management (GMP)
  
• Manage GMP change control processes (TCRs and CRs) associated with both CapEx and OpEx activities.
• Ensure all project modifications are thoroughly reviewed, approved, and documented per regulatory and organizational standards.
  

  
  

  qualifications

  • Bachelor's degree in Engineering, Biotechnology, or a related field (Master's degree preferred).
    
  • Minimum of 6-8 years of project management experience, with a strong emphasis on capital expenditure (CapEx) projects in a biopharmaceutical or GMP-regulated environment.
    
  • Proven track record of successfully managing complex, cross-functional projects from inception to qualification.
  • Solid understanding of GMP principles, validation processes, and change management procedures.
    
  • Strong leadership and team management skills, with the ability to motivate and coordinate diverse teams.
    
  • Excellent organizational and problem-solving abilities, with a focus on delivering results under tight deadlines.
    
  • Exceptional communication and stakeholder management skills, with the ability to convey technical concepts to non-technical audiences.
    
  • Expertise in project management tools and methodologies (e.g., MS Project, Primavera, or equivalent)