Abdul Jabbar
Validation Engineer @Elanco
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WORK HISTORY
Validation Engineer @Elanco
Fort Dodge, IA, US
Process Validation Engineer at Elanco, where I lead and support autoclave qualification and validation activities, including IQ, OQ, and PQ execution, thermal mapping, and validation maintenance (VMs). My role involves collaborating with cross-functional teams to ensure equipment performance, compliance, and data integrity throughout the qualification lifecycle.
EDUCATION
Jawaharlal Nehru Technological University
Mechanical Engineer
ABOUT ABDUL JABBAR
Engineering Professional experience as a Validation Engineer Professional and testing within the medical device industry with a detailed approach to process improvement, product development and implementation of lean with six sigma tools in an FDA/ISO regulated environment and Six Sigma Green belt certified. • Expertise in SPC methodologies, Minitab, technical writing skills, DOE, pFMEA, SolidWorks. Write and execute protocols (IQ/ OQ / PQ), as well as characterization Verifications. • Expertise in implementation and maintenance of ISO (14001, 14971, 9001, 9002 & 13845) and GMPs for manufacturing processes. Project management and stage gate product development; Product engineering, MSA, DFM, FDA design control, IEC 60601, ISO 14971, and configuration management. • Experienced in Product Requirement Spec (Design Specifications), Test Method Validation (TMV), Quality Plan/Traceability Matrices, Process Validation, Risk Management File (Design FMEA, Hazard Analysis), Design History File (DHF). • Collaborated with a cross functional team and participated in development and enhancement of Quality standards as per GMP requirements. Experience in CAD Software, Identifying critical processing parameters and critical quality attributes. Manage protocol execution and perform data review. • In-depth understanding of quality engineering disciplines, e.g, Design of Experiments (DOE), Six Sigma (DMAIC), Control Charts, Statistical Process Capability (SPC), Measurement System Analysis (MSA), Gage Capability Studies and Gage R&R Studies and Process Failure Mode Effect Analysis (pFMEA). • Coordinated and executed GMP System Audits for packaging and labeling. Performed Design of Experiments (DOE) to optimize settings of Label Printers. • Expertise in design and manufacturing of class II and surgical implantable and disposable medical devices such as vascular grafts and patches, injection molding, plastics, catheters. Well versed with Solid Works, compliance, Minitab, Statistical Process Controls, injection molding, Laser Welding.
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