Project Manager

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For our client, a leading Biotech CDMO in Visp (Switzerland), we are looking for a

Project Manager (6321)

in a 12 months contract, potentially extendable.

This experienced and dynamic Project Manager 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.

Key Responsibilities

Project Integration and Planning

· 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, including engineering, production, quality assurance, and validation, ensuring smooth communication and collaboration.

· Establish clear roles and responsibilities for all stakeholders, ensuring a unified approach toward achieving project objectives.

Stakeholder Coordination

· Serve as the central point of contact between EPCM, Engineering Project Manager, production staff, and other stakeholders to ensure seamless communication and collaboration.

· Align project goals and deliverables with cross-functional teams, including engineering, quality assurance, and manufacturing.

Change Management (GMP)

· Manage GMP change control processes (TCRs and CRs) associated with both CapEx and OpEx activities.

· Ensure all project modifications are thoroughly reviewed, approved, and documented per regulatory and organizational standards.

Engineering and Operational Oversight

· 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.

Documentation and Reporting

· 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.

Performance Qualification (PQ) and Validation

· 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.

Requirements

· 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.

· Proven track record of successfully managing complex, cross-functional projects from inception to qualification.

· Solid understanding of GMP principles, validation processes, and change management procedures.

· Strong leadership and team management skills, with the ability to motivate and coordinate diverse teams.

· Excellent organizational and problem-solving abilities, with a focus on delivering results under tight deadlines.

· Exceptional communication and stakeholder management skills, with the ability to convey technical concepts to non-technical audiences.

· 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.

Key Attributes

· Strategic thinker with a hands-on approach to project execution.

· Resilient and adaptable to challenges in a dynamic, fast-paced environment.

Interested? Contact us!