Senior Manufacturing Engineer

Job description

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make Exciting opportunity as a Senior Manufacturing Engineer serves as a technical leader and subject matter expert (SME) for aseptic processing, fill-finish operations, and sterile manufacturing technologies. This role provides strategic engineering support to ensure reliable, compliant, and high-performance aseptic manufacturing processes for injectable drug products (vials, syringes, cartridges, etc.). The engineer drives process optimization, contamination control, equipment lifecycle management, and continuous improvement while maintaining full compliance with cGMP, FDA, EMA, ISO, and other regulatory requirements. Key Responsibilities: - Act as the primary SME for aseptic manufacturing equipment, cleanroom environments, utilities (WFI, clean steam, compressed gases), and fill-finish systems (vial washers, depyrogenation tunnels, isolators/RABS, filling lines, cappers, lyophilizers, robotic systems, etc.). - Provide technical leadership for aseptic fill/finish operations, including process design, scale-up, validation, troublesh...