R.A. Wylan & Co. Inc.,
Career Center

Process Engineer

Location: St Louis, MO
Job Type: Direct Hire
Salary: $70,000.00 - $100,000.00
Degree: Bachelor;
Date: 12/15/2015
Job ID: 02265948
Job Description
Process Engineer (multiple openings)
The process engineer will provide engineering expertise for standardizing existing processes as well as new product launches. This role will help us ensure that we have robust, compliant, and efficient manufacturing processes.
  • Pharmaceutical manufacturing industry experience needed with one of the following dosage forms: Solids, Liquids, semi-solids and Capsules
  • Standardize existing manufacturing processes (both equipment and steps) to increase robustness and compliance.
  • Develop and implement product manufacturing process improvements for existing processes (in collaboration with the Industrial Operations Team)
  • Troubleshoot and resolve manufacturing process problems—determining root cause and corrective actions.
  • Develop process documentation and training material to support the standardized processes and new product launches.
  • Provide requested documentation to support compliance requirements for existing products and for new product regulatory filings
  • Provide process engineering recommendations to R&D during the development phases to ensure development of new products that can be manufactured robustly as the current level of existing technology (i.e. Design for manufacturing).
  • Provide process engineering recommendations to R&D on compliance and product quality during the development phase.
    • Transition new products into production working as a member of the technology transfer team to ensure that the new product meets production, quality, and compliance requirements
    • Serve as Subject Matter Expert and Trainer for material directly related to process engineering knowledge
    • Participate in kaizen events as set in the Site Transformation Plan, aiding in development of new systems of support and providing the Quality perspective to the proposed improvement
  • Bachelors Degree in Chemical or Mechanical Engineering (required)
  • 5-7 years of demonstrated increasing responsibility in a pharmaceutical cGMP environment
  • Prior proven experience in processing powders and liquids
  • Prior validated experience leading process improvement teams
  • Prior experience in Pharmaceutical or other FDA regulated industry
  • Prior experience, using lean and six sigma principles and tools.
  • Ability to travel up to 10% of time.