Validation Project Manager (Pharmaceutical, Copenhagen)

Job summary

We are looking for an experienced Validation Project Manager to lead complex CQV (Commissioning, Qualification, and Validation) projects, focusing on temperature mapping in the pharmaceutical sector. This role involves technical ownership of high-impact projects and requires strong project management skills to ensure compliance solutions are delivered effectively.

Qualifications

• Proven experience in GxP temperature mapping within the Life Science industry.
• Strong project management skills with the ability to manage multiple stakeholders and deadlines.
• Solid understanding of GxP, GDP, and regulatory requirements related to environmental monitoring and storage.
• Excellent communication skills for client interaction and translating technical requirements into actionable plans.
• Detail-oriented with a commitment to data integrity and documentation excellence.
• Fluent in English; Danish is a plus but not mandatory.

Responsibilities

• Independently manage the end-to-end lifecycle of CQV projects for pharmaceutical and logistics clients.
• Drive the strategy and execution of temperature mapping activities for various environments.
• Plan, coordinate, and prioritize resources and timelines to ensure timely project delivery.
• Develop and review qualification protocols and summary reports in compliance with GMP, GxP, and ISO standards.
• Act as a technical point of contact for clients, providing guidance on regulatory expectations.
• Support the improvement of internal procedures and documentation templates.
• Collaborate with cross-functional teams to integrate IoT solutions into client validation frameworks.
• Provide technical guidance and peer-review for validation team members.

Skills

• Strong analytical skills and attention to detail.
• Ability to work in scale-up or agile environments.
• Willingness to travel for business, primarily within the EU.

Education

• Relevant degree in a scientific or engineering discipline is preferred.

Tools

• Familiarity with validation protocols and documentation standards in the pharmaceutical industry.