Validation Engineer Role
The role of a Validation Engineer involves ensuring the quality and reliability of pharmaceutical equipment, systems, and processes.
* Design and execute validation studies to test the performance of equipment, systems, and processes.
* Develop and maintain technical documentation to support validation activities.
* Analyze data from validation studies to identify areas for improvement.
* Collaborate with cross-functional teams to implement process improvements.
* Maintain regulatory compliance by adhering to FDA and EU guidelines.
Requirements:
* Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
* Previous experience in validation or product development is an asset.
* Familiarity with GAMP, ISPE Baseline guides, and relevant regulations.
* Strong understanding of quality management systems and communication skills.
* Proficiency in MS Project and SPC packages is an advantage.