Temp-Controlled Storage Specialist (On-site)

Novo Nordisk A/S; Denmark; Remote; DKK 500,000 - 734,000; Full time

Job summary

As the subject matter expert, you’ll work closely with operators, production teams, quality stakeholders and other functions to maintain robust processes and GMP compliance.

You will contribute to optimisation projects, validation strategies and future upgrades, helping improve storage solutions and handling of raw materials.

Qualifications

• Hold a degree within biotechnology, chemistry, chemical engineering, process engineering, or a similar scientific or technical discipline.
• Experience with validation, qualification, GMP-regulated processes, or change management activities.
• Possess strong analytical skills and enjoy working with data, documentation, and process optimisation.
• Communicate effectively in both Danish and English and enjoy interacting with stakeholders at all organisational levels.
• Experience from pharmaceutical manufacturing, temperature-controlled systems, SAP, or automation-related systems is an advantage.

Responsibilities

• Owning requirements, qualification, validation, and compliance activities for designated temperature-controlled areas.
• Supporting change requests, deviations, quality cases, periodic reviews, and related GMP activities.
• Monitoring temperatures, alarms, capacity utilisation, and storage conditions to ensure operational excellence.
• Maintaining Standard Operating Procedures (SOPs) and providing training and guidance to colleagues and operators.
• Representing the area during audits and inspections and acting as a trusted advisor for temperature-controlled storage processes

Skills

Analytical skills

Biotech/ChemEng background

Danish & English communication

Process validation experience

GMP awareness

Change management experience

Education

Biotechnology

Chemistry

Chemical Engineering

Process Engineering

Tools

SAP

Automation systems

Job description

As the subject matter expert, you’ll work closely with operators, production teams, quality stakeholders and other functions to maintain robust processes and GMP compliance.

You will contribute to optimisation projects, validation strategies and future upgrades, helping improve storage solutions and handling of raw materials.