Senior Specialist, Transportation Validation (Biotechnology, Copenhagen)

Job summary

The role involves ensuring safe and compliant transportation of antibody products within the global supply chain. The Senior Specialist will lead the qualification and validation of transport solutions and equipment, driving continuous improvement while adhering to regulatory requirements.

Responsibilities

• Lead the qualification of shipping solutions and transportation equipment in collaboration with various departments.
• Validate shipping lanes for intermediates and finished goods across the global network.
• Ensure transportation solutions meet product requirements and regulatory standards.
• Plan and execute qualification activities for transportation equipment.
• Develop and maintain SOPs governing transportation validation and distribution activities.
• Conduct risk assessments to identify and mitigate supply chain risks.
• Collaborate with external logistics partners to ensure compliant distribution solutions.
• Partner with QA to maintain GxP compliance and lead investigations of deviations.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Supply Chain, or related field.
• Over 5 years of experience in transportation validation or pharmaceutical distribution.
• Strong knowledge of GxP and global regulatory requirements.
• Experience with equipment qualification and validation lifecycle.

Skills

• Patient-focused mindset with a commitment to quality and compliance.
• Collaborative approach with strong communication skills.
• Analytical thinking and structured problem-solving abilities.

Education

• Relevant degree in Life Sciences, Engineering, Supply Chain, or a related field.

Tools

• Familiarity with thermal packaging systems, temperature monitoring devices, and quality management systems.