Scientist - Process Validation

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A challenging job in our Process Validation Department in Copenhagen as a Scientist, Process Validation is open for a quality-minded new colleague with statistical process control knowledge and a strong ability to drive interdepartmental collaboration.

The Role

The role of Scientist, Process Validation offers opportunity to work with scientists involved in process validation projects from clients or from another AGC site globally into the CPH site. More specifically, the team manages all the activities required for process validation including the documentation (plans, protocols and reports); risk assessment (e.g. FMEA); mix and hold validation studies, monitoring and trending of data and change requests.

The candidate will be dedicated to managing the continued process verification (CPV) program for a specific high throughput project.

The role requires an understanding of CPV and data collection. In addition, the key elements of the role include: data trending, data interpretation, regular presentation (to internal and external stakeholders) as well data reporting.

The candidate must be able to interface with several functions to collect and assess the relevant information.

There is also the possibility to work on other process validation topics as the need arises.

The role currently reports directly to the Director of Process Validation.

Key responsibilities:

  • Manage the data collection as agreed and trending of data for the CPV program.

  • Take timely and appropriate action based on the data output.
  • Communicate and present findings at meetings at defined intervals.
  • Generate technical reports based on data at an agreed frequency.
  • Using scientific knowledge to interpret trends, propose next steps and actions required.
  • Interface with internal and external stakeholders and represent the department and the team effectively and professionally.
  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards.
  • Define and make improvements regarding data turnaround, flow of information and reporting.

The position offers a dynamic environment with plenty of learning opportunities in the field of process validation as well as all types of microbial and mammalian biopharmaceutical processing.

The role requires interaction with a large number of stakeholders. The position is unique in having contact with both our customers and all internal departments.

The Department

The Process Validation department currently consists of 13 highly skilled scientists, one director, and student helpers. The department comprises SMEs in management of PV activities, supporting studies (including risk assessments and mix and hold validation studies) as well as CPV monitoring. We have an open communication and strong support and flexibility within the department.

Your profile

Our ideal new colleague will have the following experience:

  • Degree in science, engineering, or a related field (M.Sc. or Ph.D.).
  • A strong background in applied statistics, statistical process control and / or statistical modelling.
  • Familiarity using SAS JMP.
  • A fast learner, able to understand process validation and process understanding concepts.
  • Strong technical writing and presentation skills.
  • Familiar with EMA, FDA, and ICH regulations for process validation.
  • Experience and knowledge in upstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, is desirable.
  • The company language is English, so excellent English communication skills is required.

AGC Biologics Copenhagen

AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. You will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team.

We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidate is found, the advert will close. We are therefore looking forward to receive your application today!

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.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 3.2.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København
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