Senior Validation Engineer

Role: Senior Validation Engineer responsible for planning, executing, and leading validation activities for manufacturing processes, equipment, utilities, and sterilization systems in a pharmaceutical setting. Key objectives include developing validation strategies, protocols, and documentation throughout the validation lifecycle, ensuring compliance with GMP and regulatory standards. Responsibilities encompass supporting qualification of equipment and facilities, process validation (including aseptic and sterilization cycles), troubleshooting, risk assessments, and supporting regulatory inspections. The role involves cross-functional collaboration with manufacturing, quality, and engineering teams, as well as leading risk reduction and process optimization projects. Qualifications: High school diploma with 8+ years, associate’s degree with 6+ years, or BA/BS with 2+ years of relevant experience; proven expertise in GMP, validation, and qualification of pharmaceutical processes and equipment; strong knowledge of quality systems and validation documentation. Preferred skills include experience with sterile products, medical devices, regulatory audits, and familiarity with AI tools for problem-solving. The position requires physical capability for lifting and working in controlled environments, with occasional after-hours support. Location: On-premise, with minimal travel; must be authorized to work in the U.S., no visa sponsorship available.