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Specialist for Computerized Systems Validation (CSV)

Our exiting journey continues in helping patients to a better life. AGC Biologics is expanding our current Copenhagen site with a brand new facility – an investment for approx. 160 million Euro. This expansion will more than double AGC Biologics’ single-use bioreactor mammalian cell-culture capacity in Copenhagen, enabling AGC Biologics to meet the needs of the market. The new building will have a total floor area of approximately 19,000m2 and is an important part of AGC Biologics’ global expansion plan. The facility is expected to start operating in 2023. Already now, we are looking for talented colleagues to join. If you want to be part of AGC Biologics, look at the position below and see if there is a match with your expectation for a new professional challenge.  Do you want to be part of QA Facilities & Equipment; A team of highly dedicated specialists that are responsible for validation and qualification activities for Facility, Utility, Equipment and Computerized Systems? Do you want to play a key role in bringing numerous pharmaceutical productions safely and efficiently to market?
Then join AGC Biologics in a new position as Specialist for Computerized Systems Validation (CSV) and become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time.

Specialist with qualification experience for Computerized SystemsIn our department, QA Facilities & Equipment we are working with many teams across the organization such as other QA departments, production, engineering, process development, analytical development and QC.As a Computerized Systems Validation specialist you will participate in strategic planning of computerized qualification activities, prepare SOPs, protocols and reports, and in general facilitate continuous improvement of IT compliance.
You will be responsible for tasks related to GMP-critical Computerized Systems; including Computerized Systems Validation for SCADA Facility, Utility, FMS and Computerized system for Equipment. You will participate in implementation of the new AGC facility, various IT projects and implementation of new equipment in general, where you will work closely together with system owners and provide assistance in all qualification related work.
You must enjoy performing practical Computerized Systems Validation, and at the same time have a scientific approach in trouble shooting and qualification. You must be able to handle challenges in a busy environment with a positive mind set.
Develop your GMP skills and build relations with highly skilled people from the industryYou will cooperate closely with the other teams at AGC Biologics in CPH and with colleagues from our sister sites in US, Japan and Germany in order to ensure that all quality related activities are carried out LEAN, effectively and in compliance with cGMP.

Through customer projects, audits and inspections as well as continuous improvements of the facility and processes, you are exposed to many different ways of working with GMP and pharmaceutical manufacturing, and you can expect to build great expertise within these areas by interacting with our many different international customers.
The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics - and not least to our international customers. A positive and proactive environment working together in committed and friendly collaboration characterizes your future colleagues in the department.
Your ProfileYou have experience with interpretation of global cGMP rules for computerized systems used inAPI manufacturing. Our Quality System is compliant to ICH Q7 and relevant parts of FDA 21 CFR part 11, 210, 211, 600 and 610 and ideally, you have a few years knowledge in several of the following areas:

  • Validation of computerized systems in cGMP Manufacturing areas
  • Validation of computerized systems in cGMP QC Laboratory areas
  • Facilitated computerized systems in pharmaceutical areas
  • CFR 21 Part 11 and EUDRALEX Annex 11
  • Audit trail review, part 11
  • Writing, prepare and provide training in SOPs
  • Writing qualification protocols, reports, Deviations, CAPA and Change Requests
  • Support regulatory inspections e.g. EMA, FDA and customer audits (internal and external audits)


It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.
AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent. 
AGC offersAGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. ApplicationWe continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will close.? For further information about this position, please contact Team Leader for QA Facilities & Equipment Mette Juncker on +45 22 94 30 95. Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook ! AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.  Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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