Project Manager

vor 1 Tag

Visp, Schweiz Real Staffing Vollzeit

Direct message the job poster from Real Staffing

Recruitment Consultant at SThree | Georgia Tech Scheller College of Business Alumni

Duration: 03/02/2025 to 31/12/2025
Location: Visp, Switzerland

We are seeking an experienced 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:

  1. Act as the primary point of accountability for the overall project, ensuring alignment between EPCM activities and production team initiatives.
  2. Develop and manage a comprehensive project plan, integrating timelines, deliverables, and milestones for both mechanical adaptations and operational improvements.
  3. Coordinate cross-functional teams, including engineering, production, quality assurance, and validation, ensuring smooth communication and collaboration.
  4. Establish clear roles and responsibilities for all stakeholders, ensuring a unified approach toward achieving project objectives.
  5. Serve as the central point of contact between EPCM, Engineering Project Manager, production staff, and other stakeholders to ensure seamless communication and collaboration.
  6. Align project goals and deliverables with cross-functional teams, including engineering, quality assurance, and manufacturing.
  7. Manage GMP change control processes (TCRs and CRs) associated with both CapEx and OpEx activities.
  8. Ensure all project modifications are thoroughly reviewed, approved, and documented per regulatory and organizational standards.
  9. Collaborate with the Engineering Project Manager to oversee the performance of the EPCM contractor, ensuring adherence to specifications, timelines, and quality standards.
  10. Ensure production-side operational improvements are planned, resourced, and executed effectively, minimizing disruption to existing processes.
  11. Drive compliance with GMP change management requirements, including the creation and management of Technical Change Requests (TCRs) and Change Requests (CRs).
  12. Coordinate the smooth transition from mechanical adaptations to operational improvements, ensuring readiness for performance qualification (PQ).
  13. Oversee the project's adherence to GMP standards throughout conceptual design, execution, and PQ phases.
  14. Maintain detailed project documentation, including integrated plans, change control records, and progress reports.
  15. Provide regular updates to senior management on project status, risks, and mitigation strategies.
  16. 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.
  17. Collaborate with quality assurance and validation teams to ensure the successful completion of PQ phases.

Key requirements:

  1. Bachelor's degree in Engineering, Biotechnology, or a related field (Master's degree preferred).
  2. 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.
  3. Proven track record of successfully managing complex, cross-functional projects from inception to qualification.
  4. Solid understanding of GMP principles, validation processes, and change management procedures.
  5. Strong leadership and team management skills, with the ability to motivate and coordinate diverse teams.
  6. Excellent organizational and problem-solving abilities, with a focus on delivering results under tight deadlines.
  7. Exceptional communication and stakeholder management skills, with the ability to convey technical concepts to non-technical audiences.
  8. Expertise in project management tools and methodologies (e.g., MS Project, Primavera, or equivalent).
  9. PMP (Project Management Professional) or PRINCE2 certification preferred.
  10. Lean Six Sigma certification is a plus.
  11. Strategic thinker with a hands-on approach to project execution.
  12. Resilient and adaptable to challenges in a fast-paced environment.
  13. Detail-oriented with a commitment to delivering high-quality outcomes.
  14. Holds an EU passport or valid Swiss work permit.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

Seniority level

Entry level

Employment type

Full-time

Job function

Project Management

Industries

Professional Services

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