Sr. Validation Engineer

Role: Senior Validation Engineer responsible for leading validation activities within GMP-regulated biopharma environments, supporting equipment, utilities, facilities, and computerized systems. Objectives include developing and executing validation lifecycle documents, ensuring compliance with FDA cGMP standards, and supporting complex technical projects. Responsibilities encompass authoring and reviewing IQ/OQ/PQ protocols, risk assessments, validation reports, and overseeing requalification efforts; performing P&ID walkdowns, thermal mapping, and supporting audit readiness. Requirements: Bachelor’s in life sciences, engineering, or related field; 7–11 years' experience in biotech/pharma/medical device sectors with strong knowledge of validation, FDA regulations, and GxP. Preferred skills include expertise in equipment and system validation, technical documentation, and supporting regulatory inspections. High-Value: Focus on equipment, utilities, and automated systems validation within sterile manufacturing or process development; experience with CSV, analytical methods, and process validation; supporting audits and remediation; mentoring junior team members. Work setup: Primarily remote with potential on-site requirements; no sponsorship available.