GMP Cleaning Process Leader for Pilot Plants

Novo Nordisk

Gladsaxe Kommune

On-site

DKK 651,000 - 957,000

Full time

9 hours ago
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Job summary

Novo Nordisk is seeking a Cleaning Area Process Manager to drive cleaning standards across CMC Development and its pilot plants. You will anchor cleaning concepts, close gaps, and ensure inspection readiness with GMP-compliant processes.

You will lead cross-functional collaboration to set direction and deliver training, ensuring safe, consistent manufacturing of clinical material. With a strong background in pharmaceutical cleaning and a track record in compliant manufacturing, you will

Qualifications

  • Master’s degree in engineering or Life Sciences.
  • Strong hands-on expertise in cleaning processes in the pharmaceutical industry, including cleaning concepts and systems in a GMP environment.
  • 5+ years of experience in manufacturing or production environments, with a focus on compliance and cleaning.
  • Experience with CMC and clinical manufacturing, and a solid understanding of how clinical and commercial manufacturing environments differ.
  • A thorough understanding of GMP and regulatory requirements in pharmaceutical manufacturing.
  • Fluency in English.

Responsibilities

  • Facilitate the CMC Development cleaning process group, making sure cleaning activities meet internal requirements and applicable regulatory and GMP standards.
  • Assess and act on cleaning compliance signals from authorities, audits and deviations: initiate investigations, coordinate responses and follow through on corrective and preventive actions (CAPA) with Production and QA.
  • Represent CMC Development in the Novo Nordisk cleaning process group, and help translate agreed standards into clear local procedures, training and governance.
  • Optimise cleaning methods, tools, acceptance criteria and execution with Production, QA and Maintenance – through better planning, standardisation and fit-for-purpose tools that reduce downtime.
  • Spot recurring gaps, simplify ways of working and elevate high-risk or high-impact issues to senior management when needed.
  • Develop training and onboarding materials, and give ongoing guidance so everyone involved applies cleaning requirements consistently.

Skills

Cleaning processes
Project management
Cross-functional collaboration
Training development

Education

Master’s degree in engineering or Life Sciences

Tools

GMP systems

Job description

Novo Nordisk is seeking a Cleaning Area Process Manager to drive cleaning standards across CMC Development and its pilot plants. You will anchor cleaning concepts, close gaps, and ensure inspection readiness with GMP-compliant processes.

You will lead cross-functional collaboration to set direction and deliver training, ensuring safe, consistent manufacturing of clinical material. With a strong background in pharmaceutical cleaning and a track record in compliant manufacturing, you will

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