For a well renowned company of the pharmaceutical industry, we are currently seeking a Validation Specialist for an initial 3 months mission, who will be responsible for planning, executing, and documenting qualification and requalification activities (CIP-SIP processes, HVAC), ensuring full compliance with regulatory requirements and internal quality standards.
Key Responsibilities:
Cleaning Validation
:
* Drafting validation protocols.
* Performing execution activities, including rinse water and surface sampling.
* Analyzing results and preparing final validation reports.
Sterilization Validation
:
* Writing qualification protocols.
* Executing tests, including thermocouple placement with the Kaye system and use of bioindicators.
* Interpreting data and drafting final reports.
HVAC Qualification and Reclassification
:
* Supporting qualification and requalification activities for controlled-area HVAC systems.
Digital Systems
:
* Managing and tracking validation protocols using Kneat.
Work Organization:
* On-site position.
* Standard working hours (day shifts), with flexibility to work in 2x8 shifts depending on project needs.
Profile & Qualifications:
* Scientific or technical background (Bachelor's/Master's degree or equivalent) in validation, quality, microbiology, pharmaceutical sciences, or engineering.
* Solid professional experience (senior level) in validation within a pharmaceutical, biotech, or medical device environment.
* Practical expertise in cleaning, sterilization, and HVAC qualification activities.
* Experience with digital validation management systems (ideally Kneat).
* Strong ability to work independently while collaborating effectively in a team.
* Personal qualities: rigor, flexibility, teamwork mindset, and results orientation.
Why Join Us?
* A key role at the heart of the client's quality and compliance activities.
* Continuous support during the application phase and during the mission.