Project Manager

Vor 5 Tagen

Visp, Schweiz Panda Vollzeit

We are seeking an experienced and dynamic 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.

**Key Responsibilities**
- 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.
- Align project goals and deliverables with cross-functional teams, including engineering, quality assurance, and manufacturing.
- Manage GMP change control processes (TCRs and CRs) associated with both CapEx and OpEx activities.
- Collaborate with the Engineering Project Manager to oversee the performance of the EPCM contractor, ensuring adherence to specifications, timelines, and quality standards.
- Ensure production-side operational improvements are planned, resourced, and executed effectively, minimizing disruption to existing processes.
- Drive compliance with GMP change management requirements, including the creation and management of Technical Change Requests (TCRs) and Change Requests (CRs).
- Coordinate the smooth transition from mechanical adaptations to operational improvements, ensuring readiness for performance qualification (PQ).
- Oversee the project’s adherence to GMP standards throughout conceptual design, execution, and PQ phases.
- Maintain detailed project documentation, including integrated plans, change control records, and progress reports.
- Provide regular updates to senior management on project status, risks, and mitigation strategies.
- For the execution phase, i.e. after the current conceptual design & feasibility study phase, oversee the planning and execution of validation activities, ensuring alignment with regulatory and GMP requirements.
- Collaborate with quality assurance and validation teams to ensure the successful completion of PQ phases.

**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.
- Expertise in project management tools and methodologies (e.g., MS Project, Primavera, or equivalent).
- Certifications
- PMP (Project Management Professional) or PRINCE2 certification preferred.
- Lean Six Sigma certification is a plus.

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