Aufgaben

  • Develop and oversee comprehensive plans aligning CapEx and OpEx initiatives, coordinate cross-functional teams, and define stakeholder roles
  • Act as the central liaison between EPCM contractors, production, engineering, and quality teams
  • Manage GMP-compliant change control processes (TCRs and CRs)
  • Ensure project quality and adherence to GMP standards during mechanical adaptations and operational improvements
  • Maintain detailed records and regularly report progress to senior management
  • Oversee validation activities, ensuring compliance through conceptual design, execution, and PQ phases

Qualifikationen

  • Bachelor’s in Engineering, Biotechnology, or related field (Master’s preferred)
  • Experience: 6-8 years of project management in CapEx within GMP-regulated biopharma. Proven success in managing complex, cross-functional projects
  • Strong knowledge of GMP, validation, and change management
  • Leadership, communication, and problem-solving capabilities
  • Expertise in project management tools (e.g., MS Project)
  • PMP or PRINCE2 preferred; Lean Six Sigma is a plus
  • Strategic mindset, adaptability, and attention to detail in a dynamic environment