Senior Manufacturing Engineer

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, troubleshooting, and ongoing performance monitoring. Ensure robust aseptic practices and contamination control strategies (CCS) are implemented and sustained across all sterile operations. Lead or support equipment and process lifecycle activities, including design reviews, FAT/SAT, IQ/OQ/PQ, requalification, and decommissioning. Author, review, and approve technical documents such as SOPs, batch records, change controls, deviations, CAPAs, risk assessments, validation protocols/reports, and investigation reports. Perform root cause analysis (using tools such as Fishbone, 5-Why, FMEA) for process deviations, environmental monitoring excursions, and equipment failures; implement effective corrective and preventive actions. Drive process optimization and continuous improvement initiatives using Lean, Six Sigma, and data-driven approaches to increase yield, reduce cycle time, minimize interventions, and enhance sterility assurance. Provide engineering oversight and troubleshooting support during manufacturing campaigns, including real-time shop-floor support for complex technical issues. Collaborate with Quality Assurance, Validation, Microbiology, Regulatory, Supply Chain, Operations and MSAT teams to ensure successful tech transfers, new product introductions (NPI), and regulatory inspections. Support regulatory submissions and inspections by preparing technical packages and defending aseptic processes. Mentor and provide technical guidance to junior engineers, manufacturing technicians, and cross-functional team members. Monitor and analyze process performance metrics (e.g., yield, intervention rate, environmental monitoring trends, downtime) and implement improvements. Qualifications & Requirements Bachelor’s degree (required) in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Pharmaceutical Engineering, or a related technical discipline Master’s degree or advanced technical certification preferred 7+ years of hands-on engineering experience in cGMP pharmaceutical/biotech manufacturing, with at least 5+ years focused on aseptic fill/finish operations Strong experience with isolator technology, RABS, vial/syringe/cartridge filling lines, lyophilization, aseptic connections, and closed-system processing Proven track record supporting sterile product manufacturing (small molecules, biologics, gene/cell therapies, or vaccines) Required Knowledge & Skills Deep expertise in aseptic processing principles, sterilization methods, contamination control, and Annex 1 / FDA Guidance for sterile drug products Familiarity with cleanroom design, environmental monitoring programs, media fills, and sterility assurance Strong understanding of equipment qualification, process validation, and computer systems validation (CSV) in a GxP environment Proficiency in technical problem-solving, statistical analysis (SPC, DOE, capability analysis), and risk management tools Experience authoring and defending regulatory documents during audits/inspections Excellent written and verbal communication skills; ability to present complex technical information clearly Preferred Qualifications Experience with robotic aseptic filling systems or advanced automation Knowledge of single-use systems in aseptic processing Previous experience in tech transfer, scale-up, or greenfield facility startup