Sr. Validation Engineer

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr. Sacramento, CA 95834 About the Job: Title of the Position: Sr. Validation Engineer Department: Quality Assurance Reports to: Director of Validation Job Summary The Senior Validation Engineer independently leads validation of processes, equipment, utilities, and systems supporting sterile pharmaceutical production. The role develops scientifically justified validation approaches that meet current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and company procedures. Reporting to the Director of Validation, this position manages projects through the validation lifecycle, resolves complex technical issues, reviews validation deliverables, and mentor's engineers. Responsibilities Qualification of Equipment and Systems • Independently plan, author, execute, and technically review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment and systems. • Lead qualification of sterile manufacturing equipment, facilities, and utilities, including filling lines, isolators, autoclaves, terminal sterilizers, HVAC systems, and critical utilities. • Define qualification scope, test methods, worst-case challenge conditions, and acceptance criteria based on intended use, technical requirements, and quality risk assessments. • Perform and review thermal qualification and environmental mapping studies using Kaye validation systems, temperature and relative humidity data loggers, and calibrated test instruments. Validation Documentation and Protocols • Author and technically review validation plans, user requirements, risk assessments, protocols, traceability matrices, and final reports, ensuring conclusions are supported by documented evidence. • Verify raw data, calculations, test results, and resolution of discrepancies before recommending completed studies for approval. Maintain accurate, complete, and traceable validation records. • Develop and improve validation procedures and templates; perform periodic reviews and define requalification requirements to maintain the validated state. Process Validation and Cleaning Validation • Lead assigned process performance qualification activities and support aseptic process simulations in collaboration with Production, Quality Control, Quality Assurance, and technical teams. • Coordinate validation requirements for new products, process transfers, and equipment changes, including study desig