Senior Manufacturing Engineer

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeWe are seeking an experienced Senior Manufacturing Engineer to lead technical operations and process optimization in our state-of-the-art Assembly Inspection and Packaging this critical role you will drive manufacturing excellence for pharmaceutical products (sterile and non-sterile) while ensuring full compliance with cGMP FDA EMA and other regulatory a senior technical leader you will be responsible for equipment performance process robustness continuous improvement new product introductions (NPI) Tech Transfers in high-speed automated inspection assembly and packaging ResponsibilitiesLead the design qualification and optimization of visual inspection assembly labeling and packaging processes for vials syringes cartridges auto-injectors and other pharmaceutical delivery and maintain process flow diagrams equipment specifications and critical process parameters (CPPs).Identify and implement process improvements using Lean Six Sigma and data-driven methodologies to increase throughput yield and equipment effectiveness (OEE).Lead capital and continuous improvement projects from concept through implementation including scope definition URS development vendor engagement FAT/SAT support commissioning qualification and handoff to complex manufacturing issues related to high-speed automation vision systems robotics and serialization/track-and-trace by example in safety environmental and compliance practices; identify and mitigate operational risks in manufacturing processes and execute and review validation protocols (IQ/OQ/PQ process validation and computer system validation) for new and existing all manufacturing processes remain in a validated state and comply with 21 CFR Parts 210/211 Annex 1 and ISO regulatory inspections (FDA EMA etc.) and internal audits as a subject matter expert (SME) for IAP deviation investigations CAPA implementation and change control as the primary manufacturing engineering lead for technology transfers and scale-up of new products into the IAP with Process Development Quality Assurance and Regulatory Affairs to ensure manufacturability and design for manufacturability (DFM) reviews during product select and implement new assembly packaging and inspection technologies (e.g. automated visual inspection systems high-speed labelers cartoners case packers).Manage equipment reliability programs including preventive maintenance optimization and spare parts closely with Reliability Maintenance and Automation Engineering teams on equipment uptime and and provide technical guidance to junior Manufacturing Engineers and cross-functional teams on major projects and Kaizen OEE improvement initiatives and cost reduction technical reports presentations and documentation for leadership and clientsQualifications & RequirementsBachelors degree in Mechanical Chemical or Industrial Engineering or a related technical field; masters degree 6 years of experience in pharmaceutical or biotechnology manufacturing with at least 2 years in a Senior Engineer or equivalent experience in Assembly Inspection and Packaging of sterile injectables or complex drug-device combination products is track record with high-speed automated packaging lines vision inspection systems and serialization knowledge of cGMP validation principles (GAMP 5 Risk Based approach to compliant GxP design and systems) and pharmaceutical regulatory with statistical process control (SPC) Design of Experiments (DOE) and root cause analysis tools (FMEA Fishbone etc.).Proficiency in reading technical drawings (P&ID mechanical layouts) and working with CAD with Track-and-Trace 2D coding and anti-counterfeiting Six Sigma Green Belt or Black Belt certification is highly leadership and project management technical writing and communication to thrive in a fast-paced client-focused CDMO QualificationsExperience supporting commercial manufacturing for large pharmaceutical with integrated packaging systems such as feeders labelers cartoners checkweighers case packers reject systems vision inspection and serialization/aggregation platforms experience in a multi-product CDMO management certification (PMP) or We OfferCompetitive base salary performance bonusComprehensive benefits package (health dental vision 401k etc.)Professional development and conference opportunitiesExposure to cutting-edge pharmaceutical manufacturing technologiesCollaborative and innovative work culture#LI-Onsite