Senior Process Engineer

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThis is an exciting opportunity as a Senior Process Engineer that will serve as a technical leader and subject matter expert (SME) that is responsible for the design implementation optimization troubleshooting and lifecycle management of aseptic manufacturing processes and equipment used in the production of sterile pharmaceutical and/or biopharmaceutical products. 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 ResponsibilitiesAct as the primary SME for aseptic manufacturing equipment 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 process validation troubleshooting and ongoing performance robust aseptic practices and contamination control strategies (CCS) are implemented and sustained across all sterile or support equipment and process lifecycle activities including design reviews FAT/SAT IQ/OQ requalification and review and approve technical documents such as SOPs batch records change controls deviations CAPAs risk assessments validation protocols/reports and investigation in-depth root cause analysis (using tools such as Fishbone 5-Why FMEA) on mechanical automation environmental and process deviations; author and implement CAPAs to drive permanent corrective solutions to improve yield reduce downtime and strengthen contamination 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 engineering oversight and troubleshooting support during manufacturing campaigns including real-time shop-floor support for complex technical with Quality Assurance Validation Microbiology Regulatory Supply Chain Operations and MSAT teams to ensure successful tech transfers new product introductions (NPI) and regulatory regulatory submissions and inspections by preparing technical packages and defending aseptic or significantly contribute to change controls process improvement projects and capital projects aimed at enhancing sterility assurance throughput and operational review and approve SOPs batch records preventive maintenance plans calibration procedures and engineering protocols/ cleanroom performance qualification activities including airflow visualization (smoke studies) particle monitoring pressure cascade management and personnel/material flow and provide technical guidance to junior engineers manufacturing technicians and cross-functional team and analyze process performance metrics (e.g. yield intervention rate environmental monitoring trends downtime) and implement & Requirements:EducationBachelors degree in Chemical Engineering Mechanical Engineering Biomedical Engineering Electrical Engineering or a related technical 3 years of hands-on engineering experience in a cGMP regulated pharmaceutical biopharmaceutical or sterile medical device manufacturing with isolator technology RABS vial/syringe/cartridge filling lines lyophilization aseptic connections and closed-system track record supporting sterile product Technical Skills & QualificationsProficiencyin mechanical design software: SolidWorks AutoCAD Inventor or equivalent (required: creation of complex 3D models assemblies detailed drawings and tolerance analysis).Automation knowledge: PLC programming (ladder logic structured text) HMI/SCADA development troubleshooting industrial control systems and integration of robotic arms servo systems and vision -depth knowledge of aseptic fill-finish equipment: peristaltic/rotary piston pumps vial/syringe/cartridge fillers stoppering/capping systems isolators/RABS VHP decontamination and barrier understanding of process control instrumentation sensors actuators and data acquisition with data analytics tools (Excel Minitab JMP OSIsoft PI) for process monitoring capability analysis and statistical of cGMP requirements EU Annex 1 contamination control strategy sterility assurance and cleanroom executing or leading process/equipment validation media fills and cleaning validation in aseptic to lean manufacturing Six Sigma or reliability-centered maintenance in capital project execution or technology transfer We OfferOpportunity to take ownership of high-impact aseptic systems and automation tostate-of-the-artfill-finish and barrier development path toward Principal Engineer or technical leadership salary bonus eligibility and comprehensive benefits technical training and mentorship opportunities#LI-Onsite