Senior Engineer II, Quality Validation

Role: Subject Matter Expert in validation within a biopharma or medical device environment, specializing in areas such as process, equipment, packaging, or utility validation. Objectives: support validation activities for new product introductions, transfers, and ongoing projects, ensuring compliance with cGMP, ISO, and other regulatory standards. Responsibilities: develop and execute validation protocols, assess risk, manage validation projects, and contribute to quality systems including change control and audits. Requirements: Bachelor's in Engineering or Science with 8+ years of experience in validation or QA in pharma/medical devices; strong technical knowledge, project management skills, and familiarity with validation principles and regulations. Preferred: experience with utility, equipment, process, or packaging validation, validation documentation, risk management tools, and working in a regulated environment. High-Value: validation expertise for regulated products, cGMP compliance, supporting audits and inspections. Work setup: not specified; likely team-oriented with independent responsibilities, requiring organizational and communication skills.