Job ResponsibilitiesDesign, optimize, and support pharmaceutical manufacturing processes to improve efficiency, quality, and complianceProvide day-to-day technical support for manufacturing operations, troubleshooting process and equipment issuesCollaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to support production goalsEvaluate and implement process improvements to enhance product quality, throughput, and operational performanceDevelop and maintain process documentation including batch records, SOPs, process flow diagrams, and technical reportsSupport technology transfer activities for new products and manufacturing processesMonitor process performance, analyze manufacturing data, and identify trends for continuous improvement opportunitiesParticipate in Process Failure Mode and Effects Analysis (FMEA) activities to assess and mitigate process risksAssist with process validation activities including protocol development, execution, and report generationSupport investigations related to deviations, non-conformances, and CAPA activitiesApply Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP) to ensure regulatory complianceEvaluate and support implementation of new manufacturing equipment, technologies, and automation systemsPartner with vendors and suppliers to review equipment specifications and process requirementsDrive continuous improvement initiatives focused on safety, efficiency, waste reduction, and process reliabilitySupport regulatory inspections and audits by providing technical expertise and process documentationMaintain accurate records and ensure data integrity for all engineering and manufacturing activitiesQualificationsBachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field3+ years of experience in pharmaceutical, biologics, medical device, or GMP-regulated manufacturing environmentsStrong knowledge of cGMP regulations, FDA requirements, and pharmaceutical manufacturing processesExperience with aseptic processing, sterile manufacturing, formulation, or fill-and-finish operations preferredUnderstanding of process validation, equipment qualification, and manufacturing quality systemsKnowledge of process controls, instrumentation, and manufacturing equipment systemsExperience supporting deviation investigations, CAPA activities, and change control processesFamiliarity with risk management tools such as FMEA preferredLean Six Sigma certification or continuous improvement experience preferredStrong analytical, troubleshooting, and problem-solving skillsExcellent communication, teamwork, and technical writing abilitiesAbility to manage multiple priorities in a fast-paced manufacturing environmentProficiency with Microsoft Office, manufacturing systems, and data analysis tools preferredAbility to work independently and collaboratively within cross-functional teams#J-18808-Ljbffr