Senior API Process Engineer – Transfer & Scale-Up

Novo Nordisk A/S; Kalundborg; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk Kalundborg is seeking a Senior Process Engineer in API Manufacturing to strengthen product and process understanding in a state-of-the-art production environment. You will combine chemistry, biochemistry and pharmaceutical manufacturing with data-driven methods to support stable, compliant process performance.

You will transfer a new product from development into operations, own product-related activities, and collaborate across production, development, quality and engineering to

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 pharmaceutical manufacturing experience.
• Practical knowledge of chemical modification, protein chemistry, organic chemistry, downstream processing, purification or HPLC.
• Experience with cGMP, deviations, investigations, change control, qualification or validation in a regulated setting.
• Strong English communication and stakeholder management across functions.

Responsibilities

• Driving qualification and validation activities in accordance with cGMP requirements and supporting the implementation of new products and processes.
• Developing understanding of chemical modification, protein chemistry, purification and other API steps.
• Analyzing complex process data and translating findings into improvements and monitoring strategies.
• Owning product-related activities, including deviations, investigations, change requests and transfers.
• Sharing specialist knowledge and supporting colleagues to strengthen team capability.

Skills

English communication

Stakeholder management

Ownership mindset

Independent working

Ambiguity navigation

Education

Biochemistry

Chemistry

Biotechnology

Biomedicine

Chemical Engineering

Tools

HPLC

Purification

Chemical modification

Downstream processing

Job description

Novo Nordisk Kalundborg is seeking a Senior Process Engineer in API Manufacturing to strengthen product and process understanding in a state-of-the-art production environment. You will combine chemistry, biochemistry and pharmaceutical manufacturing with data-driven methods to support stable, compliant process performance.

You will transfer a new product from development into operations, own product-related activities, and collaborate across production, development, quality and engineering to