GMP Specialist

Job title:

GMP Specialist

Company:

COWI

Job description

GMP Specialist (Pharmaceutical manufacturing facility projects)Lyngby/Ringsted/Odense/Vejle/Esbjerg/Aarhus/AalborgPermanentHybridDo you want to play a key 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? Do you have an excellent understanding of, and experience with GMP requirements for pharmaceutical facilities? And can you offer support throughout all project phases, from scoping and design to completion and handover? Then, join our GMP team to apply your knowledge and enable a better tomorrow!Shaping tomorrow – transform challenges into sustainable solutions.We work with ambitious and highly skilled customers who have the ability to shape the future and as part of COWI’s Building and Industry Division in Denmark, you will join a growing group of GMP specialists in our pharma team. The team consists of project managers, design managers and specialists and we have several hundred colleagues working in the pharmaceutical market. Our ambition is to establish an even stronger presence in this market.Your main responsibilities will be divided into two areas:Internally, you will:

• Strengthen the GMP team’s expertise in executing pharmaceutical projects by taking ownership of developing 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.

Externally, you will:

• 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.

Your skills. Our team. Together we design the future.To succeed in this role, you should have a strong desire to be part of the execution of COWI’s pharma strategy and the continuous development of the pharma team, along with curiosity and a willingness to collaborate with colleagues, partners, and customers. Building meaningful connections with others is achieved through respectful interactions and consistently delivering on your commitments. Additionally, you should remain open to exploring new insights and methods of improvement.In addition to the skills mentioned above, the ideal candidate will have:

• 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.

A Great Place to WorkAt COWI, we work 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 100% 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.With offices primarily located in the Nordic region, the UK, North America and India, we are currently more than 8,000 people who bring their expertise in engineering, architecture, energy and environment into play.Got More Questions?If you have any unanswered questions about the role or what we have to offer, please reach out to our Leading Project Manager, Arne Winther Nielsen, via email: .Get to know us even better at our website, , where you can learn more about our projects, our strategy, what we want to achieve and what life is like at COWI.We do our utmost to ensure that our recruitment process is as fair and unbiased as possible. You can help us by not including a photo in your CV when you apply.Diversity is fundamental to COWI, inclusion is key.We are committed to creating a respectful and fair work environment where all employees have a sense of belonging and equitable opportunities to thrive and grow. We ensure that our leaders are role models for inclusive leadership by cultivating a culture where diverse perspectives and thoughts are seen as strengths. And we take diversity and inclusion into account in all relevant decisions and processes and when setting teams and fora. We do it because it is part of our values and because it is simply the right thing to do.

Expected salary

Location

Syddanmark

Job date

Wed, 09 Oct 2024 22:35:00 GMT

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