Senior Manufacturing Engineer II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Engineerisresponsible forthe design implementation optimization troubleshooting and lifecycle management of aseptic manufacturing processes and equipment used in the production of sterile pharmaceutical and/or biopharmaceutical role requires strong focus on driving quality into production processes implementation of best practices and continuous role plays a key technicalroleinmaintainingsterility assurance driving equipment reliability supporting regulatory compliance (cGMP EU Annex 1) and leading or significantly contributing to process improvements automation enhancements and validation activities in ISO 5/Grade A cleanroom ResponsibilitiesEffectively manage and coordinate aseptic manufacturing technical processes and functions at the site in support of technical or independently execute the design modification optimization and qualification of aseptic process equipment and systems including filling lines isolators RABS autoclaves CIP/SIP skids formulation vessels and clean andmaintaindetailed technical documentation including P&IDs equipment specifications 3D models mechanical assemblies and detailed fabrication drawings using SolidWorks AutoCAD or equivalent CAD and optimize automation systems including PLCs (Allen-Bradley Siemens) HMIs industrial networks robotic material handling vision inspection systems and SCADA platforms used in aseptic filling and or lead equipment installation commissioning qualification (IQ/OQ/PQ) process validation cleaning validation and media fill simulations for new installations upgrades or technology in-depth root cause analysis (RCA) on mechanical automation and process deviations; author and implement CAPAs; and drive permanent corrective solutions to improve yield reduce downtime and strengthen contamination as technical SME for aseptic equipment and automation during regulatory inspections audits and risk assessments (FMEA HAZOP).Lead or significantly contribute to change controls process improvement projects and capital projects aimed at enhancing sterility assurance throughput and operational closely with Quality Assurance Validation Production Maintenance and Automation teams to ensure processesremainin a validated state and meet global regulatory expectations (FDA EMA ISO 14644 USP / EU Annex 1).Author 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 technical guidance and training to manufacturing and maintenance personnel on equipment operation troubleshooting and best in off-shift weekend or on-call support during critical manufacturing campaigns validation runs or major investigations & ExperienceBachelors degree in mechanical engineering Chemical Engineering Biomedical Engineering Electrical Engineeringor a closely related technical disciplinerequired.5 years of hands-on engineering experience in a cGMP-regulated pharmaceutical biopharmaceutical or sterile medical device manufacturing experience supporting or leading aseptic processing sterile fill-finish or cleanroom QualificationsExperience executing or leading process/equipment validation media fills and cleaning validation in aseptic with data analytics tools (Excel Minitab JMP OSIsoft PI) for process monitoring capability analysis and statistical to lean manufacturing Six Sigma or reliability-centered maintenance in capital project execution or technology transfer projects.