Senior Process Engineer, Cleaning

Novo Nordisk; Kalundborg; On-site; DKK 652,000 - 957,000; Full time

Job summary

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.

Qualifications

• 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.

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 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.

Education

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

Job description

Your impact begins here

As Senior Process Engineer, Cleaning, you will keep cleaning processes in API manufacturing stable, validated and continuously improving. You will use data and process science to find root causes, make the case for improvements that matter, and help colleagues grow into subject matter experts. Your work protects product quality in Kalundborg, so more people living with serious chronic diseases can rely on their treatment every day.

What You’ll Bring

You are systematic, curious about the science behind a clean process and comfortable taking ownership. You bring:

• A Bachelor’s or Master’s degree in a relevant scientific or technical discipline.
• 6+ years of experience within cleaning in pharmaceutical or API manufacturing.
• The 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.
• The ability to monitor data, extract insight from it and recommend actionable alternatives, with an appetite for analytical methods.
• The 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.

Useful, But Not Essential

• Experience with equipment qualification and process validation (IQ, OQ, PV).
• Experience coaching colleagues or contributing to inspections.

What You’ll Do

You will be a driving force for cleaning process understanding in your area, turning data and experience into stable, compliant and continuously improved processes.

• 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.

Who You’ll Work With

In Global Manufacturing & Supply, colleagues work across the value chain to scale molecules, processes and products for the people who need them. You will join API IO M3 Process Support in Kalundborg, Denmark, reporting to [insert hiring manager name and title]. Every day you will work closely with colleagues in your own department, including Associate Managers, Quality Coordinators, administrative employees and team members. You will also collaborate with other departments across the area to secure good collaboration, systematic problem solving and timely product delivery. You will share knowledge across API manufacturing facilities, forums and process groups, and communicate results to managers and department managers, and at times to senior leaders within API. Together, you will keep priorities clear and move forward with urgency.

What You Can Expect Here

You will have a high degree of independence within your area, and we expect you to challenge current practices and take initiative. You will be trusted to make your voice heard and to deliver your best work.

The role is built for growth. You will deepen your expertise in cleaning validation and process qualification, strengthen your stakeholder management skills across departments, and learn from colleagues across API facilities while helping others develop.

Salary:

For this role, the Annual Base Salary ranges from 651,600 to 956,900 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits:

The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy here