Senior Technical Project Manager

Job summary

The Senior Technical Project Manager is tasked with leading intricate engineering, manufacturing, and process development projects aimed at enhancing capacity within a global manufacturing network. This role is crucial in the introduction of new production equipment and the successful execution of strategic investment projects across various production sites.

Qualifications

• At least 5 years of Project Management experience in a manufacturing setting.
• Background in Medical Devices, Pharmaceuticals, or another regulated industry.
• Proven experience in managing cross-functional projects involving Production, Engineering, and Quality Assurance.
• Familiarity with FDA QSR, GMP, ISO 13485, or similar regulations.
• Practical knowledge of process validation and experience with FAT and SAT.
• Experience in handling CapEx projects and budgets.

Responsibilities

• Manage projects related to the manufacture, optimization, and implementation of production equipment.
• Conduct validations for designated processes and perform FAT and SAT runs for new equipment.
• Ensure compliance of documentation with current regulations and oversee 0-series production in collaboration with Development and Quality Departments.
• Maintain continuous oversight of project plans, including deadlines, resources, and finances.
• Ensure production equipment meets competitive pricing and compliance with legal and regulatory standards.
• Develop process equipment for new products and increase capacity in partnership with Logistics.
• Present project status at monthly Steering Group Meetings and maintain effective communication with project team members.

Education

Travel Requirements

Working Conditions

• Engineering degree in Mechanical, Manufacturing, Marine, or a similar technical field (required).
• Formal Project Management training/certification (PMP, Prince 2, etc.) is preferred.
• Travel may be required up to 50% of the time, primarily within Europe and Mexico, with overnight stays expected.
• This position is based at the Osted, Denmark site and operates under a hybrid working arrangement.