Senior Process Engineer, Cleaning — Data-Driven Process Excellence

Novo Nordisk; Kalundborg; In loco; DKK 652.000 - 957.000; Tempo pieno

Descrizione del lavoro

Novo Nordisk in Kalundborg, Denmark, is seeking a Senior Process Engineer, Cleaning, to keep cleaning processes in API manufacturing stable, validated and continuously improving. You will use data and process science to identify root causes and justify improvements that matter.

You will lead cleaning validation and process qualification, develop colleagues, and support inspections. A Bachelor’s or Master’s in a relevant field with 6+ years of cleaning experience is expected.

Competenze

• Bachelor’s or Master’s degree in a relevant scientific or technical discipline.
• 6+ years of experience in 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.
• Ability to explain complex information to different audiences and bring people on board.
• A quality mindset, respectful teamwork and the independence to make sound decisions.
• Experience with equipment qualification and process validation (IQ, OQ, PV) is a plus.
• Experience coaching colleagues or contributing to inspections is a plus.

Mansioni

• 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 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 area inspection-ready, take part in inspections and share best practice with colleagues across API.

Formazione

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

Descrizione del lavoro

Novo Nordisk in Kalundborg, Denmark, is seeking a Senior Process Engineer, Cleaning, to keep cleaning processes in API manufacturing stable, validated and continuously improving. You will use data and process science to identify root causes and justify improvements that matter.

You will lead cleaning validation and process qualification, develop colleagues, and support inspections. A Bachelor’s or Master’s in a relevant field with 6+ years of cleaning experience is expected.