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Manufacturing Engineer

Kindeva Drug Delivery

Manufacturing EngineerAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.The Impact You Will MakeWe are seeking a motivated and detail-oriented Manufacturing Engineer to support technical operations in our Inspection, Assembly & Packaging plant. This role will support the monitoring and optimization of assembly, visual inspection, labeling, and packaging processes for vials, syringes, cartridges and other pharmaceutical products.Key ResponsibilitiesSupport achievement of safety, quality, delivery, and cost objectives for operations.Assist in developing and updating process documentation, including SOPs, batch records, and process flow diagrams.Collect and analyze production data to identify opportunities for improving yield, throughput, and Overall Equipment Effectiveness (OEE).Participate in troubleshooting manufacturing issues related to automated packaging lines, vision systems, and serialization equipment.Assist in the execution of validation protocols (IQ/OQ/PQ, process validation) for inspection, assembly and packaging equipment.Support deviation investigations, CAPA implementation, and change control processes.Help maintain equipment and processes in a validated state in accordance with cGMP, FDA, and EMA regulations.Participate in internal audits and prepare documentation for regulatory inspections.Collaborate with cross-functional teams (Process Development, Quality Assurance, and Production) to ensure smooth scale-up and successful product launches.Track actions, timelines, and deliverables to support project execution and site priorities.Support equipment qualification, preventive maintenance, and calibration activities.Work with senior engineers and maintenance teams to improve equipment reliability and uptime.Learn and support the operation of high-speed automated inspection systems, assembly and packaging lines.Participate in Lean and continuous improvement initiatives (Kaizen events, 5S, etc.).Prepare technical reports and presentations as required.Support daily production floor activities and provide engineering support during manufacturing campaigns.Qualifications & RequirementsBachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.3+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environment.Basic understanding of cGMP principles and pharmaceutical regulatory requirements.Strong analytical and problem-solving skills.Familiarity with statistical tools, root cause analysis, and Microsoft Office (Excel, Word, PowerPoint).Ability to read and interpret technical drawings and equipment manuals is a plus.Preferred QualificationsInternship or co-op experience in pharmaceutical manufacturing or packaging operations.Knowledge of Lean Manufacturing or Six Sigma principles.Familiarity with automated inspection systems, serialization, or high-speed packaging equipment.Experience working in a cleanroom or GMP environment.What We OfferCompetitive base salary + performance bonusComprehensive benefits package (health, dental, vision, 401k, etc.)Structured mentorship and professional development programsExposure to cutting-edge pharmaceutical manufacturing technologiesClear career progression path toward Senior Manufacturing Engineer rolesCollaborative and supportive work cultureOpen to relocation for qualified candidates

Vacancy posted 11 hours ago
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