Project Manager

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.

Interested? Send your CV to Daria at [email protected] or call +41445514407 for more info