Senior Validation Engineer

Role: Senior Validation Engineer responsible for leading validation activities within GMP-regulated biopharma manufacturing environments. Primary objectives include developing and executing validation lifecycle documents for equipment, utilities, facilities, and computerized systems, ensuring compliance with FDA cGMP standards. Responsibilities encompass authoring validation protocols and reports, supporting tech transfer projects, overseeing qualification activities (IQ, OQ, PQ), conducting system requalifications, and supporting regulatory audits and inspections. Requirements: Bachelor's in life sciences or engineering; 7–11 years’ experience in biotech, pharma, or medical devices; strong knowledge of validation principles, FDA cGMP, and risk-based validation; extensive experience with automated systems validation and CSV. Preferred skills include excellent communication, organization, problem-solving, and mentorship abilities. High-value biopharma specifics: focus on equipment, utilities, and system validation in sterile or GMP environments, supporting complex manufacturing and tech transfer projects, with experience in audit support and regulatory compliance. Work setup: primarily office-based with physical demands including computer use and light lifting; environment is typical of GMP manufacturing sites. Salary range: $115,000–$130,000 annually.