We are currently recruiting a Process Validation Specialist on behalf of one of our clients, as a contract assignment running until the end of the year.
Role Overview:
As the Process Validation Specialist, you will be primarily responsible for designing the process validation strategy. You will lead the preparation of validation documentation, including study designs, protocols, and reports, ensuring alignment with client procedures and compliance with relevant regulatory guidelines.
Additional responsibilities include supporting R&D teams during the process characterization phase, as well as reviewing and approving related documentation. You will also oversee validation assessments for process changes and deviations.
As a subject matter expert, you will manage and maintain a comprehensive Continued Process Verification (CPV) plan. Furthermore, you will be responsible for assessing and approving Product Quality Reviews (PQRs).
Key Requirements:
-Master’s degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or a related field.
-Proven experience in project management, ideally within Operations, MSAT, Quality, or Compliance functions.
-Strong track record of cross-functional collaboration and communication with internal stakeholders and regulatory bodies (e.g., Swissmedic, FDA) is an asset.
-Ability to manage multiple tasks simultaneously while meeting deadlines.
-Proficiency in English (written and spoken); German language skills are a plus.
