Process Cleaning Engineer for GMP API Manufacturing

Novo Nordisk; Kalundborg; On-site; DKK 570,200 - 838,100; Full time

Job summary

Novo Nordisk is expanding its API purification capabilities with a focus on robust cleaning solutions. As a Process Cleaning Engineer, you will design, validate, and implement CIP/cleaning processes for a new API facility.

You will work with engineering, validation, and manufacturing teams to ensure compliance and operational excellence. We seek candidates with GMP experience, strong collaboration skills, and a passion for delivering high-quality solutions in a regulated environment.

Qualifications

• Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related discipline.
• GMP-regulated environment experience preferred in pharma, biotech, or API manufacturing.
• Knowledge of production processes, process equipment, validation activities, and GMP documentation practices.
• Experience with CIP, cleaning validation, qualification activities, or process engineering is a plus.
• Professional proficiency in English; Danish is considered a plus.

Responsibilities

• Drive CIP activities across the project lifecycle from design to validation.
• Support design reviews, risk assessments, and verification activities; troubleshoot as needed.
• Ensure GMP compliance and quality standards in validation efforts.
• Collaborate with internal and external stakeholders, contractors, and project teams.
• Contribute to risk management and development of future cleaning standards for API manufacturing.

Skills

GMP experience

CIP experience

English proficiency

Process validation understanding

Education

Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related discipline

Job description

Novo Nordisk is expanding its API purification capabilities with a focus on robust cleaning solutions. As a Process Cleaning Engineer, you will design, validate, and implement CIP/cleaning processes for a new API facility.

You will work with engineering, validation, and manufacturing teams to ensure compliance and operational excellence. We seek candidates with GMP experience, strong collaboration skills, and a passion for delivering high-quality solutions in a regulated environment.