Process Engineer, API Manufacturing — Scale-Up & Impact

Novo Nordisk; Kalundborg; On-site; DKK 570,000 - 838,000; Full time

Job summary

Novo Nordisk in Kalundborg is seeking a Process Engineer for API Manufacturing to bring a new product into large-scale production. You will combine chemistry/biochemistry knowledge with process data to understand reactions and purification steps, turning insights into stable, compliant manufacturing.

You'll own product-transfer activities as the project moves into operations, support deviations and validations, and collaborate with production, development, quality and engineering to deliver

Qualifications

• A Bachelor’s, Master’s or PhD in biochemistry, chemistry, biotechnology, biomedicine, chemical engineering or another relevant life-science discipline.
• Relevant experience from pharmaceutical manufacturing, API production, biotechnology or another chemistry-intensive production environment.
• Practical knowledge of chemical modification, protein chemistry, organic chemistry, downstream processing, purification, filtration or HPLC.
• Working knowledge of cGMP in a regulated setting.
• Strong English communication skills and the ability to share knowledge, collaborate across functions and influence decisions.
• Curiosity, a proactive approach and enjoyment in solving complex challenges.

Responsibilities

• Build a detailed understanding of how the molecule, chemical modification, protein chemistry and purification steps affect the final product.
• Analyse process data to find correlations and root causes, and turn the findings into practical improvements and monitoring.
• Support qualification and validation activities in line with cGMP requirements, and the implementation of new products and processes.
• Take ownership of product-related activities such as deviations, investigations, change requests, product transfers and continuous improvement.
• Share your specialist knowledge, contribute to technical decisions and help build capability in a growing team.

Skills

Biochemistry degree

Chemistry degree

Pharma/manufacturing experience

cGMP knowledge

English communication

Curiosity/problem solving

Education

Bachelor/Master/PhD in life sciences

Job description

Novo Nordisk in Kalundborg is seeking a Process Engineer for API Manufacturing to bring a new product into large-scale production. You will combine chemistry/biochemistry knowledge with process data to understand reactions and purification steps, turning insights into stable, compliant manufacturing.

You'll own product-transfer activities as the project moves into operations, support deviations and validations, and collaborate with production, development, quality and engineering to deliver