Validation Engineer

We are seeking an experienced Validation Engineer specializing in lyophilization processes and equipment. The ideal candidate will lead validation activities, ensuring compliance with regulatory standards while supporting manufacturing excellence in a pharmaceutical or biotech setting.

Requirements

• Develop and execute validation protocols for lyophilization equipment and processes.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for lyophilizers.
• Create, review, and maintain validation documentation, including protocols, reports, and risk assessments.
• Conduct validation testing to meet regulatory and industry compliance standards.
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing.
• Address validation issues and implement corrective and preventive actions (CAPA).
• Stay updated on industry trends and regulatory changes related to lyophilization and validation.
• Participate in audits concerning validation processes.
• Provide training and guidance on validation protocols and best practices.