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 for a unique opportunity to shape the validation/qualification direction for computerized software in AGC Biologics? Do you have a quality mindset and are you eager to contribute your energy and talent in a in a highly engaged team? Then join us as Senior IT Validation Scientist in Process Engineering & Validation Department
Your responsibilities in the role
AGC Biologics CPH continues to enjoy great success, and we are expanding our portfolio of interesting project in our new state of the art multipurpose production facility. With this new production facility and a steadily increasing number of computerized validation/qualification activities – we are going to need strong skilled IT minded validation/qualification experts with expertise for driving validation activities end-2-end 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 activitites
- 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 department that will be looking forward to have you on board
You will be a part of Process Engineering & Validation Department, where currently 24 highly qualified team members are waiting for you. We share a fun/relaxed tone while at the same time have high ambitions to deliver best in class validation/qualification activities across the entire organization, to benefit our global biopharmaceutical costumers.
Why we would will like to have you as part of the team
In our new colleague, we are looking for a person with:
- 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 the role
- 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
- Good team player, open minded and result-orientated.
- Ability to effectively communicate with a broad audience of stakeholders
We will process the applications in the order they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. Please be aware that we only take applications into consideration that are send via our career page. Please note, the hiring process for this position will begin in Week 32.
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.