Get latest jobs before others

Scientist, Process Validation (Temporary position, 18 months)

AGC Biologics

Copenhagen, Denmark

Job Summary
AGC is looking for temporary (18 months) scientist within the Process Validation Department in Copenhagen, which requires process validation knowledge and a strong ability to drive interdepartmental collaboration.

The role of Process Validation Scientist offers opportunity to lead, coordinate and oversee process validation activities for late stage projects from initiation to completion. The Process Validation Scientist will be responsible for providing technical input to internal and external stakeholders as required throughout the process validation lifecycle. This includes 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.

Key responsibilities:

  • Plan, organize and execute process validation activities for drug substance manufacturing (e.g., mixing and hold validation, continued process verification).
  • Generate process validation plans, protocols and reports in a timely manner and according to project requirements.
  • Use scientific knowledge to analyze and interpret data, propose next steps and actions required. Take timely and appropriate action based on the data output.
  • Interface with internal and external stakeholders and represent the department and the team effectively and professionally.
  • Communicate and present findings at meetings as required.
  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards.

The Department
The Process Validation department currently consists of 10 highly skilled scientists, 1 director, 3 managers and a student assistant. The department comprises Subject Matter Experts (SMEs) in management of PV activities, supporting studies (including risk assessments and mix and hold validation studies) as well as Continued Process Verification (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:

  • Degree in biological science, engineering, or a related field (minimum M.Sc.).
  • relevant experience in process validation within biopharmaceutical production and GMP is a plus
  • Strong technical writing and presentation skills.
  • Familiar with EMA, FDA, and ICH guidelines for process validation.
  • Experience and knowledge in upstream and downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, is desirable.
  • A fast learner with a positive mindset and drive.
  • The company language is English, so excellent written and spoken English communication skills are 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 to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

This job posting is collected from company pages and is only shown as short resume. Read entire job ad here:

view full ad at AGC Biologics

save deadline
mail me
Application deadline: as soon as possible
Geographic location

Applicant interest

How much interest does this ad generate among job seekers? Log in to see how popular this job posting is.


Please specify in your application, that you've found this ad in Akademikernes Jobbank

Job type
Student job
Temporary job
Greater Copenhagen
Chemistry, Biotech & Material Sciences
Natural Sciences
Work area
Data & Analytics
Medico & Health Services
Natural Sciences
Research & Development
Get latest jobs before others

AGC Biologics at a glance

AGC Biologics
AGC Biologics
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production, using mammalian and microbial production systems.


Vandtaarnsvej 83B
2860 Søborg

Logo: AGC Biologics
Job market demand

What types of job and work areas are we usually offering?

View statistics
Unsolicited applications

We are happy to receive unsolicited applications

Are there other information about us, that you should know? See what Google Search tells you.
Karriereprofil i Jobbanken
Create career profile: Automate your job search with job agents, get latest career opportunities before others and get visible to employers with talent profile.