Sr. Validation Engineer

Job description

Responsible for leading qualification and validation activities for equipment, manufacturing processes, utilities, and raw materials within a parenteral pharmaceutical manufacturing facility. The role involves preparing and executing validation protocols, generating validation reports (GTRs), managing change controls, and supporting equipment installation, commissioning, qualification (IQ/OQ/PQ), and process validation activities. The candidate will work closely with Production, Engineering, Planning, QC, QA, and Testing Laboratories to ensure compliance with cGMP, FDA, MHRA, and other regulatory requirements. Responsibilities include investigating manufacturing issues, implementing process improvements, supporting regulatory submissions, maintaining validation documentation, participating in internal and external audits, and serving as a project lead for cross-functional validation projects. The position also requires mentoring junior team members, providing technical leadership, and ensuring validation activities are completed on schedule while maintaining the highest standards of quality, compliance, and operational excellence.