Senior It Validation Scientist

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you ready to shape the validation and qualification direction for computerized software at AGC Biologics? Do you possess a quality-focused mindset and a drive to contribute your energy and talent to a highly engaged team? Join us as a Senior IT Validation Scientist in Facility &
Equipment Validation, located in Søborg (Greater Copenhagen).

The Role
AGC Biologics is experiencing significant growth, and we are expanding with a brand-new mammalian production facility in Copenhagen, set to be operational in 2024. With this expansion and a growing number of computerized validation and qualification activities, we need highly skilled IT experts to drive end-to-end validation processes for computerized software.

Key responsibilities:

• Responsible for performing computerized qualification test and protocols, compiling data and completing validation reports for implementation of new software.
• Oversight the different validation activities from planning, execution to completion.
• Updating and optimizing current procedures when needed, such as PART 11 Data integrity activities.
• Report on progress and milestones to stakeholders.

The position offers interaction with different stakeholders both from the site in CPH but also from talented colleagues around the global AGC network. You will be introduced to global biopharmaceutical companies and be an active player in their projects.

The Team
You will join the Facility &
Equipment Validation department, comprised of 14 highly qualified and dedicated team members. We maintain a relaxed and collaborative atmosphere while striving for excellence in delivering top-tier validation and qualification activities across the organization. Our goal is to benefit our global biopharmaceutical customers with the highest standards of quality and precision.

Why We Want You on Our Team
We believe your expertise and passion for validation activities will be a valuable addition to our team. Your skills and insights will help us achieve our high ambitions and continue to deliver exceptional results for our global clients. Join us and be part of a team that values collaboration, innovation, and excellence.

Ideally, you have...

• A relevant academic background and at least 5 years of relevant experience with GMP/IT/validation.
• You have experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in
• Experience with PART 11, GAMP 5, Data integrity from a GxP environment, would be seen as a plus.
• Make things happen in a context of high complexity
• Excellent English language skills both verbally and written
• Good team player, open minded and result-orientated.
• Ability to effectively communicate with a broad audience of stakeholders

Are you up for the challenge?

• Apply with your CV (in English, please).
• If we see a match, you will have a call with one of our recruiters to share more about what you can bring to the team.
• Are both sides still positive? You'll be invited to a first interview.
• We will conduct ongoing interviews and close the position once the successful candidate is found.
• For any further questions, are you welcome to contact Jeppe Palm Beckmann on [email protected].

Our culture at AGC Biologics is defined by the six core values:
Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington;
Boulder and Longmont, Colorado;
Copenhagen, Denmark;
Heidelberg, Germany;
Milan, Italy;
and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.Agcbio.Com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Location:
Copenhagen Site

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