Principal Process Engineer – Filling

Role Summary

The principal process engineer - Filling plays a critical role as a technical leader and Subject Matter Expert in sterilization, aseptic filling, sealing and handling of sterile drug product to ensure manufacturing processes operate safely, efficiently and in compliance with regulatory standards.

• Use data to track performance and guide decisions.
• Utilize optimization resources and tools for process analysis and process improvement studies.
• Ensure systems remain in a qualified state and are appropriate for use.
• Ensure maintenance and calibration activities are established and periodically reviewed for trends – generate action plans for improvements, if needed.
• Ensure maintenance and calibration activities are established and periodically reviewed.
• Apply statistical thinking and methods to understand process variability and capability, and establish/drive improvements, accordingly.
• Assist with and review documents related to key learning points, technical analyses, and investigations of incidents.
• Guide engineers in process expertise, problem-solving, critical thinking, project management, design and excellence in execution. Review and approve documentation/decisions requiring “responsible” engineer level of authority.
• Lead or participate in root cause analysis and countermeasure development and implementation of major safety, quality, or throughput incident investigations. Performs review of incident documentation for technical accuracy.
• Identify process bottlenecks and assist in prioritization of opportunities with respect to overall business objectives.
• Act as a key contact during audits (quality, HSE), ensuring adherence to regulatory requirements and site inspection readiness.
• Develop project scopes for both short- and long-term capital projects, serving as user representative or project manager when needed.
• Sponsor and manage technology transfers, and improvement initiatives from concept through execution.
• Lead or assist with root cause analysis and countermeasure implementation for major safety, quality, or throughput incidents. Review incident documentation for technical accuracy.
• Support development and technical analysis for long term large-scale initiatives such as productivity improvements, GMP remediation, and safety risk mitigation.
• Review and track key process engineering metrics.
• Coach junior engineers, promote standardization of technical procedures, and foster alignment with global engineering principles.
• Support development of training and training material for cross-functional teams including operations, QA, MSAT.

• Required:
  
  Bachelor’s degree in engineering
• Required:
  
  10+ years senior engineering experience in a parenteral manufacturing site
• Required:
  
  5+ years of aseptic filling operation experience
• Required:
  
  Solid understanding of basic requirements of regulatory agencies
• Required:
  
  Product tech transfer experience
• Required:
  
  Equipment trouble shooting experience
• Required:
  
  Previous facility or area start up experience
• Required:
  
  Prior experience working effectively with a cross functional group including network and/or global functions
• Required:
  
  Excellent interpersonal, written, and oral communication skills
• Required:
  
  Strong technical aptitude and ability to train and mentor others
• Required:
  
  Ability to handle multiple competing priorities
• Preferred:
  Previous experience for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Preferred:
  Previous experience with highly automated equipment
• Preferred:
  Previous experience with Optima PFS lines
• Preferred:
  Previous equipment qualification and process validation experience
• Preferred:
  Previous experience with Manufacturing Execution Systems and electronic batch release.
• Preferred:
  Previous experience with CMMS systems
• Preferred:
  Previous experience with deviation and change management systems including Trackwise

• Bachelor’s degree in engineering

• Day Shift, possible after-hour support
• Project Delivery and/or Plant Shutdown may coincide with company holidays
• Occasional travel may be required for training, conferences, capital projects, etc.