CapEx and OpEx Integration Specialist

Vor 2 Tagen

Visp, Schweiz Randstad Staffing Vollzeit

Job Description


As a Biopharmaceutical Project Manager, you will 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.


Key Responsibilities


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

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