Manufacturing Engineer 2

Job Summary We 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 Responsibilities Provide on-floor technical leadership during aseptic bulking, cleaning, milling, and filling operations Monitor critical process parameters, environmental controls, and batch execution to ensure compliance with cGMP and aseptic standards Deliver real-time troubleshooting support for deviations, process upsets, and equipment issues Lead and support root cause investigations, deviations, CAPAs, and change controls Author clear, inspection-ready technical reports and documentation Partner cross-functionally with Manufacturing, Quality, Engineering, Validation, and MS&T teams Develop and improve SOPs, work instructions, batch records, and control documentation Support process validation, cleaning validation, and ongoing process monitoring Drive continuous improvement initiatives to enhance yield, reduce variability, and improve aseptic behaviors and equipment performance Provide training and technical coaching for operators and new team members on aseptic practices and process understanding Support regulatory inspections, internal audits, and compliance activities Required Qualifications Bachelor's degree in Chemical Engineering or related scientific or engineering discipline 3+ years of experience in pharmaceutical or biotech manufacturing, process development, or MS&T roles At least 2 years of hands-on experience supporting aseptic manufacturing operations Strong knowledge of sterile processing, aseptic technique, and cGMP requirements Proven ability to troubleshoot process issues and perform root cause analysis Experience with technical documentation, including deviations, CAPAs, and investigations Strong analytical and problem-solving skills, including use of data-driven tools Excellent written and verbal communication skills with cross-functional teams Ability to work independently and make sound technical decisions in real time Preferred Qualifications Experience supporting commercial pharmaceutical manufacturing operations Background in process validation, cleaning validation, or continued process verification Familiarity with statistical analysis, experimental design, and process capability tools Experience with process automation, equipment optimization, or new technology implementation Prior exposure to regulatory inspections and audit readiness