GMP Cleaning Process Lead - Pilot Plant

Novo Nordisk A/S; Gladsaxe Kommune; Presencial; DKK 651.000 - 957.000; Jornada completa

Descripción de la vacante

Novo Nordisk A/S in Denmark is seeking a Cleaning Area Process Manager to set cleaning standards across CMC Development, ensuring GMP compliance and inspection readiness for pilot plants producing material for clinical trials.

You will drive the cleaning compliance agenda, lead cross-functional teams, translate standards into local procedures, and develop training to ensure consistent application of cleaning requirements across Production, QA and Maintenance.

Formación

• Master's degree in engineering, Life Sciences or a related field.
• 5+ years in manufacturing or production with focus on compliance and cleaning.
• Experience with GMP, CMC and clinical manufacturing.
• Fluency in English.

Responsabilidades

• Facilitate the CMC Development cleaning process group, ensuring activities meet internal, regulatory and GMP standards.
• Assess and act on cleaning compliance signals from authorities, audits and deviations; initiate investigations and coordinate CAPAs.
• Represent CMC Development in Novo Nordisk cleaning process group and translate standards into local procedures, training and governance.
• Optimize cleaning methods, tools, acceptance criteria and execution with cross-functional teams to reduce downtime.
• Identify recurring gaps and elevate high-risk issues to senior management when needed.
• Develop training and onboarding materials and provide ongoing guidance on cleaning requirements.
• Support hands-on cleaning tasks in the Purification Pilot Plant and across API Pilots DK.

Conocimientos

Cleaning processes expertise

English fluency

Project management

Educación

Master's degree in engineering, Life Sciences or related field

Descripción del empleo

Novo Nordisk A/S in Denmark is seeking a Cleaning Area Process Manager to set cleaning standards across CMC Development, ensuring GMP compliance and inspection readiness for pilot plants producing material for clinical trials.

You will drive the cleaning compliance agenda, lead cross-functional teams, translate standards into local procedures, and develop training to ensure consistent application of cleaning requirements across Production, QA and Maintenance.