Senior Validation Engineer – Aseptic Processing | GMP Manufacturing

We're partnering with an innovative organization at the forefront of cell and gene therapy manufacturing to find a Senior Validation Specialist/Aseptic Filling Technician . This is an exciting opportunity to join a growing team supporting sterile manufacturing operations and helping bring life-changing therapies to patients. If you have experience with aseptic processing, validation, and GMP manufacturing and enjoy working in a collaborative, fast-paced environment, we'd love to connect! What You'll Do Lead and support aseptic process simulations (Media Fills) . Execute and support process validation activities for sterile manufacturing. Develop, review, and execute validation protocols and reports. Collaborate with Manufacturing, Quality, Engineering, and Microbiology teams. Investigate deviations and implement CAPAs. Support contamination control and environmental monitoring initiatives. Ensure compliance with FDA, cGMP, and regulatory requirements. Participate in continuous improvement projects to optimize manufacturing processes. What We're Looking For Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific field. Experience in GMP pharmaceutical, biologics, or cell & gene therapy manufacturing . Hands-on experience with Media Fill (Aseptic Process Simulation) . Experience with process validation , IQ/OQ/PQ , PPQ , or related validation activities. Knowledge of aseptic manufacturing, contamination control, and cleanroom operations. Experience with deviations, CAPAs, and change control. Strong communication and cross-functional collaboration skills. Why Join? Work on cutting-edge therapies that make a real difference in patients' lives. Join a collaborative and innovative manufacturing environment. Competitive compensation and comprehensive benefits. Career growth opportunities within a rapidly expanding organization. #J-18808-Ljbffr