Manufacturing Engineer 2

Job SummaryWe are seeking a hands-on Manufacturing Engineer II to provide on-floor technical leadership for aseptic manufacturing operations. This individual will serve as a key technical resource supporting sterile production processes, ensuring compliance, driving right-first-time performance, and improving process reliability and efficiency across the product lifecycle.This role combines real-time problem solving with structured investigation and continuous improvement in a fast-paced pharmaceutical manufacturing environment.Key ResponsibilitiesProvide on-floor technical leadership during aseptic bulking, cleaning, milling, and filling operationsMonitor critical process parameters, environmental controls, and batch execution to ensure compliance with cGMP and aseptic standardsDeliver real-time troubleshooting support for deviations, process upsets, and equipment issuesLead and support root cause investigations, deviations, CAPAs, and change controlsAuthor clear, inspection-ready technical reports and documentationPartner cross-functionally with Manufacturing, Quality, Engineering, Validation, and MS&T teamsDevelop and improve SOPs, work instructions, batch records, and control documentationSupport process validation, cleaning validation, and ongoing process monitoringDrive continuous improvement initiatives to enhance yield, reduce variability, and improve aseptic behaviors and equipment performanceProvide training and technical coaching for operators and new team members on aseptic practices and process understandingSupport regulatory inspections, internal audits, and compliance activitiesRequired QualificationsBachelor's degree in Chemical Engineering or related scientific or engineering discipline3+ years of experience in pharmaceutical or biotech manufacturing, process development, or MS&T rolesAt least 2 years of hands-on experience supporting aseptic manufacturing operationsStrong knowledge of sterile processing, aseptic technique, and cGMP requirementsProven ability to troubleshoot process issues and perform root cause analysisExperience with technical documentation, including deviations, CAPAs, and investigationsStrong analytical and problem-solving skills, including use of data-driven toolsExcellent written and verbal communication skills with cross-functional teamsAbility to work independently and make sound technical decisions in real timePreferred QualificationsExperience supporting commercial pharmaceutical manufacturing operationsBackground in process validation, cleaning validation, or continued process verificationFamiliarity with statistical analysis, experimental design, and process capability toolsExperience with process automation, equipment optimization, or new technology implementationPrior exposure to regulatory inspections and audit readiness