Senior Cleaning Process Engineer: Validate & Optimize

Novo Nordisk A/S; Kalundborg; Remote; DKK 652,000 - 957,000; Full time

Job summary

Novo Nordisk A/S in Kalundborg, Denmark, seeks a Senior Process Engineer, Cleaning, to keep cleaning processes in API manufacturing stable, validated and continuously improved. You will use data and process science to identify root causes and advocate improvements that matter for product quality and patient outcomes.

You will work with GMP and cGMP principles, contribute to cleaning validation, process optimisation and inspections readiness, and develop colleagues into subject matter experts

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific or technical discipline.
• 6+ years of experience within cleaning in pharmaceutical or API manufacturing.
• Ability to independently understand the scientific principles behind cleaning, including how chemistry and equipment interact.
• Experience working independently with cleaning validation and process optimisation.
• Strong GMP knowledge and good documentation practice according to cGMP.
• Ability to monitor data, extract insight from it and recommend actionable alternatives, with an appetite for analytical methods.

Responsibilities

• Support daily process execution and troubleshooting, using systematic problem solving to find root causes and drive continuous improvement.
• Use data to visualise, analyse and explain process performance, and drive standardisation of tasks, data collection and analysis.
• Build scientific understanding of the process, linking it to product quality and recommending optimisation projects, with a clear justification for each.
• Develop and perform process confirmation, and grow your responsibility for cleaning validation and other types of process qualification and validation.
• Develop colleagues with more than two years’ experience into subject matter experts, keeping an ongoing dialogue on their individual development plans.
• Keep your area inspection-ready, take part in inspections and share best practice with colleagues across API.

Skills

GMP knowledge

Data analysis

Root cause analysis

Process understanding

Documentation practice

Education

Bachelor’s or Master’s degree in a relevant scientific or technical discipline

Tools

IQ/OQ/PV

Job description

Novo Nordisk A/S in Kalundborg, Denmark, seeks a Senior Process Engineer, Cleaning, to keep cleaning processes in API manufacturing stable, validated and continuously improved. You will use data and process science to identify root causes and advocate improvements that matter for product quality and patient outcomes.

You will work with GMP and cGMP principles, contribute to cleaning validation, process optimisation and inspections readiness, and develop colleagues into subject matter experts