Senior Quality Engineer

Job Summary We are seeking a highly experienced Senior Quality Engineer to support packaging validation, equipment qualification, process validation, and manufacturing quality activities within a regulated manufacturing environment. The ideal candidate will have strong expertise in IQ/OQ/PQ validation, packaging and post-sealing equipment validation, statistical analysis, process capability, and Quality Management Systems (QMS) . Lead and execute equipment qualification and process validation activities, including IQ, OQ, and PQ. Develop and review validation protocols, reports, test procedures, acceptance criteria, and related documentation. Support packaging validation, including post-sealing and packaging equipment validation. Provide Quality Engineering support to manufacturing operations and troubleshoot process and equipment‑related quality issues. Perform statistical analysis, process capability studies, and data analysis to evaluate process performance and identify improvement opportunities. Support the investigation and resolution of nonconformances, deviations, complaints, and CAPAs. Lead or participate in Root Cause Analysis (RCA) using appropriate problem‑solving methodologies. Develop, review, and implement inspection and testing procedures to ensure product and process requirements are met. Ensure manufacturing processes and validation activities comply with applicable Quality Management Systems (QMS), regulatory requirements, and company procedures. Support internal, external, and regulatory audits and inspections by providing technical documentation and validation evidence. Identify opportunities for Lean Manufacturing, process optimization, and continuous improvement. Collaborate with Manufacturing, Quality, Engineering, Operations, and other cross‑functional teams to resolve technical and quality issues. Provide technical support for equipment/process changes, validation requirements, and manufacturing improvements. Prepare and maintain accurate technical and quality documentation in accordance with applicable procedures and regulatory requirements. Monitor process performance and recommend corrective or preventive actions based on data and risk assessment. Participate in design/process reviews, risk assessments , and change control activities as required. Job Summary We are seeking a highly experienced Senior Quality Engineer to support packaging validation, equipment qualification, process validation, and manufacturing quality activities within a regulated manufacturing environment. The ideal candidate will have strong expertise in IQ/OQ/PQ validation, packaging and post‑sealing equipment validation, statistical analysis, process capability, and Quality Management Systems (QMS) . Roles & Responsibilities Lead and execute equipment qualification and process validation activities, including IQ, OQ, and PQ. Develop and review validation protocols, reports, test procedures, acceptance criteria, and related documentation. Support packaging validation, including post‑sealing and packaging equipment validation. Provide Quality Engineering support to manufacturing operations and troubleshoot process and equipment‑related quality issues. Perform statistical analysis, process capability studies, and data analysis to evaluate process performance and identify improvement opportunities. Support the investigation and resolution of nonconformances, deviations, complaints, and CAPAs. Lead or participate in Root Cause Analysis (RCA) using appropriate problem‑solving methodologies. Develop, review, and implement inspection and testing procedures to ensure product and process requirements are met. Ensure manufacturing processes and validation activities comply with applicable Quality Management Systems (QMS), regulatory requirements, and company procedures. Support internal, external, and regulatory audits and inspections by providing technical documentation and validation evidence. Identify opportunities for Lean Manufacturing, process optimization, and continuous improvement. Collaborate with Manufacturing, Quality, Engineering, Operations, and other cross‑functional teams to resolve technical and quality issues. Provide technical support for equipment/process changes, validation requirements, and manufacturing improvements. Prepare and maintain accurate technical and quality documentation in accordance with applicable procedures and regulatory requirements. Monitor process performance and recommend corrective or preventive actions based on data and risk assessment. Participate in design/process reviews, risk assessments , and change control activities as required. Education & Experience Bachelor's degree in engineering, Quality Engineering, Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Life Sciences, or a related technical field. Advanced degree or relevant professional certifications in Quality, Validation, or Engineering are a plus. 5+ years of experience in Quality Engineering, Manufacturing Quality, Validation Engineering, Process Engineering, or a related field. Experience working in a regulated manufacturing environment, preferably within Medical Devices, Pharmaceuticals, Biotechnology, or other highly regulated industries. Experience with packaging validation and post‑sealing/packaging equipment validation. #J-18808-Ljbffr Katalyst CRO