Process Engineer II

At Miyoshi America you will find the opportunity to build your career and develop professionally within a diversified company whose motto is “Treating You Right”. Our culture encourages independent thinking and a team mentality. Consider joining a team of talented and dynamic individuals that are supporting the growth of a Global company.

Position Summary:

The Process Engineer II is responsible for process design for new product launches, optimization of current manufacturing processes, and investigation and development of corrective actions and preventive actions (CAPA) when issues arise. In conjunction with the regulatory team, the Process Engineer II ensures that the company and its marketed products are in compliance with local and global regulatory requirements by working with our customers, our internal product/sales managers, our raw material, packaging, and secondary processes vendors, regulatory agencies, consultants and others.

Responsibilities:

  • Key leader in the Technical Development Team responsible for the technical transfer and scale-up of new products developed in R&D by identifying and developing appropriate processes and product/process specifications.
  • Works with the Technical Center, Quality Unit, and other relevant departments to transfer the scale-up of products originally manufactured at other Miyoshi sites to Miyoshi America, ensuring optimal manufacturing processes, the same product quality specifications, and regulatory compliance.
  • Performs tests and monitors performance of processes throughout stages of manufacturing to determine degree of control over variables such as temperature, mix dynamics, hydrophobicity, viscosity, specific gravity, and color.
  • Develops and updates manufacturing and product specifications as needed, utilizing the appropriate change controls and validations.
  • Develops validation protocols for Cosmetic raw materials and Active Pharmaceutical Ingredients (API) that utilize current Good Manufacturing Processes (cGMP).
  • Leads process and product non-conformance investigations with the Quality Unit and troubleshoots problems within manufacturing processes. Develops corrective actions and preventive actions (CAPA).
  • Writes technical papers and reports and prepare standards and specifications for processes. Ability to collect data and organize in an appropriate format to allow review.
  • Works to continuously optimize batch manufacturing processes to reduce out of specification incidences.
  • In conjunction with the regulatory team, ensure that all manufactured products meet local and global regulations as needed.
  • Other duties as assigned

Qualifications:

  • Bachelor’s Degree in Chemistry or Engineering preferred. Relevant experience will be considered for qualifications.
  • 5+ years of experience
  • Experience in the personal care industry or chemical industry preferred
  • Strong knowledge of CFR Title 21, FDA, and GMP policies and procedures
  • Basic knowledge of inorganic and organic chemistry and interfacial chemistry
  • Ability to manage multiple, high level projects concurrently
  • A self-starter with proven critical thinking and problem-solving skills
  • Good communication skills/can work within a team and lead a team on projects
  • Highly organized with ability to prioritize
  • Strong trouble shooting and resolution skills
  • Excellent knowledge of MS Office
  • Willingness to work hands-on with process equipment
  • Ability to work independently, collaboratively, and cross-functionally (internally and externally)

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Markets Served
Color Cosmetics
Skin Care
Speciality Literature
Formulary
Photocatalytic TIO2 & ZnO