Validation Engineer - Biotech & Pharma

Validation Engineer - Biotech & pharma

KEY WORDS: Process engineer, Validation engineer, Operational excellence engineer, lean six sigma, CRA, CRM, Clinical research associate, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, Freelance, Interim, zzp, contract, project, temporary, pharma

Location: Randstad area (the Netherlands)
Duration contract: 9 months
Start date: 5th of September

About the company

Our client is a well established research, development and manufacturing company that provides production services to the pharmaceutical and biotechnology industry. With offices in Europe, Asia and the United States they have a global reach. The facility in the Netherlands provides cGMP manufacturing and sterile filling or parenteral drugs.

Right now I'm looking for a freelance validation Engineer responsible for re-validating protocols for equipment, processes and test systems for a 9 month project.

About the role

As a validation engineer your main responsibilities are the development and execution of protocols and reports for equipment, process, utility, test, and software validations and re-validations.

Furthermore you will:

*Perform Preventive Maintenance and Calibration tasks
*Support internal and external audits on validation and metrology issues.
*Report to Department Management on regulatory compliance issues related to validation

Ideally your profile looks like this:

*BS degree in Chemistry, Biology, Chemical Engineering or equivalent
*Experience in an FDA-regulated environment with multiple years experience in Validation or Metrology
*Experience with validation tools and processes including temperature mapping and the Kaye Validator
*Experience with FDA and EU regulations for pharmaceuticals and medical devices.
*Good written and oral communication skills.
*Ability to work well with other technical departments.
*Computer literate with good working knowledge of spread sheet software

If you are exited about this opportunity after reading the job description and you feel you're the right person for the job, then please do not hesitate sending your CV to Floris Peereboom, (see below) .

Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.