Computer System Validation Engineer

Location Amsterdam, Netherlands
Discipline: Biotechnology, Pharmaceutical, Medical Device, Engineering
Job type: Temporary/Freelance
Contact name: Gemma Dozy

Contact email: g.dozy@panda-int.com
Job ref: 11274
Published: 19 days ago

At the moment I am looking for a CSV Expert for one of our biotechnology clients in Amsterdam. It starts with a six month contract, however extension is expected.

Responsibilities

  • As a CSV subject matter expert, you work on development, modification and evaluation of validation processes relating to computerized systems. You give support to production (operations), continuous improvement and projects. This means you will have an attractive diversity of activities:
  • You are the advisor or lead in improvement projects regarding computerized system compliance
  • You act as process owner in the area of CSV and automation and you are involved in activities such as audits, knowledge sharing, collaborate with and advise internal customers, determine priorities
  • You determine the policy on your area of expertise, in consultation with the CoE Director and IT Director, and thereby contribute to quality improvement in production
  • You provide guidance, support and training for validation and compliance aspects of the computer systems.

Profile

  • Master’s degree; technical/scientific background preferred
  • Pharmaceutical or other regulated industry work experience for multiple years, of which minimum 2 years in CSV
  • Affinity with project management and documentation management
  • Preferred experience with computerized QMS (Trackwise), eDMS (DocCompliance) and SAP
  • Interpersonal skills, engaged in contact with personnel at all levels within the organization
  • A working attitude focused on initiative and collaboration, also the ability to work independently;
  • Written and oral communication skills in English and, if necessary, willing to learn Dutch
Interested?

If you’re interested in the above description, please apply with your CV.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at g.dozy@panda-int.com