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
FAQs
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