On-site Temperature-Controlled Operations Specialist

Novo Nordisk; Kalundborg; On-site; DKK 500,000 - 734,000; Full time

Job summary

Novo Nordisk in Kalundborg seeks a dedicated Supporter for Temperature Controlled Areas to ensure reliable operation, GMP compliance, and continuous improvement across M1 storage facilities. You will be the subject matter expert, collaborating with operators, production teams and QA to optimise processes and storage handling.

Joining a large, global team, you will contribute to future upgrades, validation strategies and storage optimisation, while maintaining SOPs and facilitating audits.

Qualifications

• Degree in biotechnology, chemistry, chemical engineering or process engineering.
• Experience with validation, qualification, GMP regulated processes or change management.
• Strong analytical skills and data/documentation handling.
• Fluent Danish and English communication across levels.
• Experience from pharmaceutical manufacturing, temperature-controlled systems or SAP/automation is a plus.

Responsibilities

• Own requirements, qualification, validation and compliance for designated temperature-controlled areas.
• Support change requests, deviations, quality cases, periodic reviews and GMP activities.
• Monitor temperatures, alarms, capacity utilization and storage conditions for ops excellence.
• Maintain SOPs and provide training to colleagues and operators.
• Represent area during audits and inspections and advise on storage processes.

Skills

Analytical skills

Data handling

Stakeholder communication

Problem solving

Team collaboration

English communication

Education

Biotechnology degree

Chemistry degree

Chemical engineering degree

Process engineering degree

Tools

SAP

Automation systems

Job description

Novo Nordisk in Kalundborg seeks a dedicated Supporter for Temperature Controlled Areas to ensure reliable operation, GMP compliance, and continuous improvement across M1 storage facilities. You will be the subject matter expert, collaborating with operators, production teams and QA to optimise processes and storage handling.

Joining a large, global team, you will contribute to future upgrades, validation strategies and storage optimisation, while maintaining SOPs and facilitating audits.