GMP Specialist

4 weeks ago

Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark COWI Full time
About the Role

We are seeking a highly skilled GMP Specialist to join our team in Denmark. As a key member of our pharma team, you will play a crucial role in building a strong internal environment with the capacity, knowledge, and services needed to execute projects and provide advisory services to our customers within the life sciences and pharmaceutical sectors.

Key Responsibilities
  • Develop qualification and validation concepts for new builds, refurbishments, reconstructions, and development projects.
  • Educate and guide project members while preparing internal procedures to ensure consistent quality and compliance within the GMP framework.
  • Manage the full scope of GMP requirements in pharmaceutical projects to strengthen our position as a preferred partner and broaden our market presence.
  • Take responsibility for CQV activities on clean rooms, temperature-regulated rooms, utilities, and other GMP-regulated areas across project teams and departments.
  • Collaborate closely with project teams and customers, serving as a sparring partner to understand and meet their requirements and expectations.
Requirements
  • In-depth understanding of GMP requirements and risk-based approach for pharmaceutical production (API and finished products).
  • Expertise in developing strategies for equipment and facility qualification/validation, and preparing documentation for risk assessment, commissioning, qualification, validation, and execution.
  • Knowledge of clean room and containment-controlled facility design, including biosafety and GMO requirements.
  • Relevant academic background (bachelor's or master's degree in engineering, biology, chemistry, or pharmacy).
  • Minimum 3 years of experience in the bio- and pharmaceutical industry, both in Denmark and internationally.
  • Strong communication skills in English (written/verbal), with Danish proficiency preferred.
  • Experience in QA or pharmaceutical production, internal training, and contributing to GMP and facility design, focused on quality and systematic documentation.
About COWI

COWI is a leading consulting engineering company that works together with our customers to shape a sustainable and liveable world. We do it by applying our knowledge and curiosity – and sometimes even our courage – to create the solutions the world needs today to enable a better tomorrow. That is why we say no to fossil-based projects and aspire to have % of our revenue come from activities that move our customers towards sustainability.

We value differences and development and cultivate an environment of belonging and having fun. Because that is what brings out the best in you, at work and at home.

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