Validation Engineer

Kashiv Biosciences is seeking a Qualification, Validation and QMS Engineer for their Biosimilar Manufacturing facility in Ahmedabad, Gujarat. This role involves ensuring engineering compliance, equipment qualification, validation, and maintaining a robust QMS system. Responsibilities include preparing SOPs, coordinating with other departments, and responding to audits.

Requirements

• Responsible for Engineering compliance, Equipment Qualification, Validation and QMS activity.
• Representing as a Subject Matter Export of Engineering in front of regulatory auditors.
• Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness.
• Responsible for technical agreements with vendors.