Process Validation Specialist Role
The Process Validation Specialist is responsible for ensuring that all manufacturing processes are validated to meet regulatory requirements.
Key Responsibilities:
* Design and execute process validation studies for equipment, systems, and processes.
* Develop and maintain validation documentation throughout the validation lifecycle.
* Collaborate with cross-functional teams to ensure compliance with regulatory standards.
* Provide technical guidance on current regulations and industry best practices.
* Support site change control processes and participate in external regulatory inspections.
Requirements:
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering.
* 3-5 years of experience working in a healthcare manufacturing environment.
* Ability to troubleshoot validation issues associated with projects and process development.
* Knowledge of pharmaceutical plants and current process validation regulations.
* Competent understanding of GAMP, ISPE Baseline guides, and steam and dry heat validation publications.