Process Validation Specialist

Vor 2 Tagen


Aubonne VD, Waadt, Schweiz Randstad Vollzeit
Job Opportunity

We are seeking a skilled Process Validation Expert to join our team at Randstad. As a key member of our Fill & Finish Department, you will be responsible for leading and managing all drug product site technical activities within our client site in Aubonne.

Your primary focus will be on ensuring the supply of New Biologic Entities (NBEs) and business continuity and product-lifecycle activities on legacy products portfolio, in compliance with specifications, registration, and GMP requirements.

Key responsibilities include:

  • Technical transfer, process validation, and commercial manufacturing campaign activities coordination
  • Coordination of production troubleshooting/investigation and potential support, if required
  • Coordination with Pharmaceutical Development entities
  • Training of Aubonne site personnel
  • Internal/External audits

Requirements

To succeed in this role, you will need:

  • Degree in Biotechnology, Process Engineering, Pharmacy, or related subject
  • Minimum of 3 years of experience in technology transfer, in R&D/Manufacturing environment
  • Demonstrated success record in leading projects, using project management tools and process improvements
  • Sound awareness of bio-pharmaceutical business
  • Sound awareness of GMP related issues and Health Authorities' requirements
  • Fluent in French and English


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