CIP & GMP Cleaning Engineer – API Facility Expansion

Novo Nordisk; Kalundborg; On-site; DKK 570,000 - 838,000; Full time

Job summary

Novo Nordisk is expanding its API purification capabilities and seeks a Process Cleaning Engineer to design, develop, validate, and implement cleaning processes that meet GMP and day-to-day operational needs. You’ll work on CIP activities across the project lifecycle, from design through commissioning, qualification, and validation.

You will join a major expansion within Novo Nordisk’s API Manufacturing, collaborating with engineering, automation, validation, and manufacturing colleagues to

Qualifications

• Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry or a related discipline.
• Experience working in a GMP-regulated environment, preferably in pharmaceutical, biotech or API manufacturing.
• Knowledge of pharmaceutical production processes, process equipment, validation activities and GMP documentation practices.
• Professional proficiency in written and spoken English.
• The ability to collaborate across disciplines, work through technical challenges and take ownership in a regulated, project-driven environment.
• Danish language skills are useful but not essential.

Responsibilities

• Drive CIP activities across the project lifecycle from design to validation.
• Participate in design reviews, risk assessments, engineering runs, testing and troubleshooting.
• Support validation activities and ensure GMP compliance and internal quality standards.
• Collaborate with contractors, engineering partners, project teams and manufacturing representatives to keep decisions clear and progress.
• Contribute to risk management and continuous improvement for future API cleaning standards.

Skills

GMP experience

Pharmaceutical production knowledge

English proficiency

Cross-disciplinary collaboration

Ownership mindset

Education

Bachelor’s degree or higher in Engineering/Pharma/related

Job description

Novo Nordisk is expanding its API purification capabilities and seeks a Process Cleaning Engineer to design, develop, validate, and implement cleaning processes that meet GMP and day-to-day operational needs. You’ll work on CIP activities across the project lifecycle, from design through commissioning, qualification, and validation.

You will join a major expansion within Novo Nordisk’s API Manufacturing, collaborating with engineering, automation, validation, and manufacturing colleagues to