Senior API Process Engineer — Scale-Up and cGMP Excellence

Novo Nordisk A/S; Denmark; Remote; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk A/S in Kalundborg is seeking a Senior Process Engineer to strengthen product and process understanding in a state-of-the-art API manufacturing environment. You will combine chemistry, biochemistry and manufacturing with data-driven methods to drive robust improvements and transfer products from development to operations.

You will work across production, development, quality and engineering, owning product-related activities and building capability within a growing team.

Qualifications

• Bachelor’s, Master’s or PhD in biochemistry, chemistry, biotechnology, biomedicine, chemical engineering or another life-science discipline.
• At least five years of relevant experience, preferably within pharmaceutical manufacturing, API production, biotechnology or another chemistry-intensive production environment.
• Experience with cGMP, deviations, investigations, change control, qualification or validation in a regulated setting.
• Strong English communication and stakeholder management skills, with the ability to influence decisions, share knowledge and collaborate across functions.

Responsibilities

• Driving qualification and validation activities in accordance with cGMP requirements and supporting the implementation of new products and processes.
• Developing a detailed understanding of chemical modification, protein chemistry, purification and other critical API process steps.
• Analysing complex process data, identifying correlations and root causes, and translating findings into robust improvements and monitoring strategies.
• Taking ownership of product-related activities, including deviations, investigations, change requests, product transfers and continuous improvement initiatives.
• Building organisational capability by sharing specialist knowledge, influencing technical decisions and supporting colleagues in a growing team.

Skills

Strong English communication

Stakeholder management

Education

Bachelor's/Master's/PhD in biochemistry/chemistry/biotechnology/biomedicine/chemical engineering

5+ years of relevant experience in pharma manufacturing

Job description

Novo Nordisk A/S in Kalundborg is seeking a Senior Process Engineer to strengthen product and process understanding in a state-of-the-art API manufacturing environment. You will combine chemistry, biochemistry and manufacturing with data-driven methods to drive robust improvements and transfer products from development to operations.

You will work across production, development, quality and engineering, owning product-related activities and building capability within a growing team.