Manufacturing Engineer 2

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.

• 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
  
  

• 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
  
  

• 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