GMP Specialist, Denmark

Titlul postului:

GMP Specialist, Denmark

Companie

COWI

Descrierea postului

GMP Specialist – Help shape the future of Pharma FacilitiesLyngby/Ringsted/Odense/Vejle/Esbjerg/Aarhus/AalborgPermanentHybridDo you want to be the bridge between vision and compliance in cutting-edge pharma projects? Can you turn regulatory rigor into seamless execution-from design to handover? And are you the go-to expert who thrives where precision meets innovation? Then, come join us as a GMP Specialist and redefine what’s possible in pharma facilities-together.Are you passionate about GMP and pharmaceutical facility projects?
We’re looking for GMP Specialists to join our consulting team, where you’ll help strengthen both our internal capabilities and provide expert advice to customers within the life science and pharmaceutical sectors, ensuring GMP compliance across multiple projects and client needs. With your strong understanding of GMP requirements and project executing experience, you’ll contribute across all phases – from early scoping and design to final qualification and handover. Join our GMP team and put your expertise to work – enabling safer, smarter pharma facilities and enable a better tomorrow.Shaping tomorrow – transform challenges into sustainable solutions.At COWI, we collaborate with ambitious, forward-thinking clients who are helping to shape the future of the life science industry. As part of our Building and Industry division in Denmark, you’ll become a key member of our dedicated and expanding Pharma team, consisting of GMP specialists, project managers, and design leads. With several hundred colleagues already engaged in pharmaceutical projects across COWI, our ambition is to establish an even stronger presence in this market – and we invite you to be part of that journey.As a GMP Specialist at COWI, you will play a crucial role in supporting pharma-regulated projects as part of a dynamic consulting team. Your work will bridge the gap between non-GMP and GMP-compliant environments, ensuring that pharmaceutical facilities are built to comply with regulatory standards.Your main responsibilities will be divided into two areas:Internally, you will:

• Develop qualification and validation strategies for pharma facilities in collaboration with project teams.
• Create and maintain GMP procedures and best practices to ensure consistent and efficient delivery across all client projects, acting as a key consultant for internal teams on GMP-related decisions.
• Share your expertise by guiding project members, enhancing their knowledge and ensuring regulatory adherence in all project phases.

Externally, you will:

• As a trusted consultant, you will guide clients through the complexities of GMP compliance, offering tailored advice and solutions that meet regulatory needs into actionable plans and solutions.
• Lead GMP activities on client’s projects, from design to execution and handover, ensuring compliance with pharmaceutical regulations 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.

Your skills. Our team. Together we design the future.To succeed in this role, you’ll need a strong drive to contribute to the execution of COWI’s pharma strategy and support the ongoing development of our pharma team. Engage in cross-functional collaboration with internal teams, external partners, and clients to tailor GMP strategies and ensure the successful implementation of compliant solutions across diverse projects. Building meaningful relationships through respectful interactions and consistently delivering on your commitments. You should also be open to exploring new ideas, continuously seeking improvements and sharing insights.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).
• Proven 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).
• 5-10 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, including internal training, and contributing to GMP and facility design with a focus 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 Head of Division, Kristian Fischer Salto, via email: .Get to know us even better at our , 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.#LI-Hybrid#LI-PRKI

Salariu așteptat

Locație

Danmark

Data jobului

Tue, 29 Apr 2025 22:53:53 GMT

Pentru a ne ajuta să urmărim efortul nostru de recrutare, vă rugăm să indicați în e-mailul/scrisoarea de intenție unde (jobsineu.net) ați văzut această postare de locuri de muncă.