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.
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
- 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 d.finikova@panda-int.com or call +41445514407 for more info