Project Engineer - Fill & Finish (m/w/d)

The Project Engineer – Fill & Finish will provide engineering expertise for the new plant extension at Takeda Neuchâtel (NFA Project). This role spans project planning, execution, and reporting, collaborating with internal teams and equipment manufacturers.

Key Responsibilities:

• Serve as the primary technical contact for the project.
• Contribute to detail engineering, project scheduling, and downtime planning.
• Organize, monitor, and review project activities with internal and external stakeholders.
• Manage communication between stakeholders to meet project objectives and timelines.
• Conduct project risk analysis and propose corrective actions or improvements.
• Define and update qualification documents with quality and validation teams.
• Ensure project documentation is current and aligned with QRM methodology and ASTM 2500.
• Support maintenance and calibration activities related to the project.
• Apply best engineering practices and corporate standards throughout the project lifecycle.
• Act as a backup for other Engineering Work Packages (EWP) when required.

Deliverables:

• Support commissioning, SAT, and qualification (PQ) of assigned EWP equipment, including aseptic filling systems, lyophilizers, isolators, CIP systems, autoclaves, sterile filtration, and material preparation.
• Ensure alignment with cGMP, GEP, SUVA/ASIT, and other industry standards.
• Define and implement safety measures to mitigate risks during project execution.
• Maintain project documentation and support project updates, including HAZOP reviews.

Routine Tasks:

• Stay up to date with required training for all listed activities.
• Provide bi-weekly updates to the plant engineering manager after the initial two months.
• Maintain on-site presence during SAT activities.

Requirements:

• Experience with aseptic filling systems and related equipment.
• Strong understanding of engineering best practices and regulatory standards.
• Ability to manage communication, risk, and documentation in a complex project environment.