Validation is a critical aspect of ensuring the reliability and safety of systems, equipment, and processes within a healthcare manufacturing environment.
As a Validation Engineer, you will play a pivotal role in executing protocols, designing validation studies, and providing technical guidance to ensure compliance with regulatory standards.
* Executing FAT/SAT/IOQ protocols involving generation of protocols and reports.
* Designing and executing validation studies for equipment, systems, and processes.
* Managing validation studies in accordance with applicable standards and regulations.
* Providing technical interpretation and guidance on current validation requirements.
* Maintaining accurate validation documentation throughout the lifecycle.
* Participating in external regulatory inspections and audits.
Requirements:
* Degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical, or Electrical).
* 3-5 years' experience in a healthcare manufacturing environment, preferably in the pharmaceutical sector.
* Proven troubleshooting skills for validation issues associated with projects and process development.
* Strong technical knowledge of pharmaceutical plants and processes.
* Previous validation and product development experience is highly advantageous.