Process Engineering Manager

8 hours ago

College Station, Texas, United States Mentor Technical Group Full time
Job Overview

Mentor Technical Group is seeking a highly skilled Process Engineering Manager to join our team. As a key member of our technical operations team, you will be responsible for providing engineering, troubleshooting support, and technical expertise for process equipment and site utilities.

Key Responsibilities:

  • Provide engineering support and technical expertise for process equipment and site utilities.
  • Identify and develop solutions to engineering problems and opportunities.
  • Lead and manage new equipment/systems installation, including infrastructure, connectivity, and capacity assessments.
  • Lead process improvements, corrective and preventive actions (CAPAs), and change controls implementation for process equipment and site utilities.
  • Support new product introductions (NPIs) and work with process sciences to develop new equipment/systems/process design, controls, requirements, specifications, and drawings.
  • Liaise with CAPEX team for the implementation of capital projects and coordinate execution of projects, improvements, and other engineering activities.
  • Oversee contractors and ensure proper testing, inspection, and release after completion of engineering activities.
  • Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
  • Ensure new equipment operates in compliance with required EHS, regulations, and codes.
  • Develop, write, edit, and/or review SOPs, P&IDs, and maintenance procedures for new equipment and/or systems.
  • Communicate efficiently with contractors, suppliers, OEM providers, and internal equipment owners and operators for a successful operation of the FDBT facility.
  • Ensure compliance with internal quality protocols and SOPs, including cGMP and FDA regulatory guidelines, within the areas of responsibility.

Requirements:

  • Bachelor's Degree in Electrical, Chemical, Mechanical, or Biomedical Engineering.
  • Six (6) years of qualified experience in an engineering role in an FDA-regulated research or manufacturing facility.

Working Environment:

  • The employee will work in a fast-paced, state-of-the-art, alternately research and customized manufacturing facility.
  • The employee may be exposed to wet and/or humid conditions, and an odorous atmosphere, and may be exposed to fumes and the risk of electrical shock.

Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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