Process Engineer

4 days ago


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

Mentor Technical Group is seeking a highly skilled Process Engineer to join our team. As a Process Engineer, you will be responsible for providing technical support and expertise for process equipment and site utilities. You will work closely with cross-functional teams to identify engineering problems and develop feasible solutions.

Key Responsibilities
  • Technical Support: Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed.
  • Problem Solving: Proactively identify engineering problems or opportunities and apply technical expertise to develop and present feasible solutions.
  • Project Management: Lead and manage new equipment/systems installation including infrastructure, connectivity and capacity assessments.
  • Process Improvements: Lead and manage process improvements, corrective and preventive actions (CAPAs) and change controls implementation for process equipment and site utilities.
  • Equipment Identification: Lead the identification of new equipment including but not limited to proper type, size, materials of construction, throughput, operational conditions, physical dimensions, required utilities, waste requirements, user requirements specifications (URS) and others.
  • New Product Introductions: Support new product introductions (NPIs).
  • Collaboration: Work with process sciences in developing new equipment/systems/process design, controls, requirements, specifications and drawings.
  • CAPEX Team Liaison: Liaison with CAPEX team for the implementation of capital projects.
  • Project Coordination: Coordinate execution of projects, improvements and other engineering activities.
  • Contractor Oversight: Oversee contractors when implementation and/or corrections are required.
  • Quality Assurance: Works with QA/QC to ensure proper testing, inspection and release after completion of engineering activities.
  • Validation and Commissioning: Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
  • Regulatory Compliance: Ensure new equipment operates in compliance with required EHS, regulations and codes.
  • Documentation: Develop, write, edit and/or review in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems.
  • Communication: Communicate efficiently with Contractors, Suppliers, OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.
  • Collaboration and Teamwork: Able to work with other contractors, manufacturing, validations and quality control personnel regarding changes or improvements to the systems.
  • Compliance and Documentation: Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate.
  • Training and Development: Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures.
  • Safety and Well-being: Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications.
  • Continuous Learning: Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
  • Professionalism: Maintain a positive, professional, and customer-oriented attitude.
Requirements and Qualifications
  • Education: Bachelor's Degree preferably in Electrical, Chemical, Mechanical or Biomedical Engineering.
  • Experience: Six (6) years of qualified experience in an engineering role in an FDA regulated research or manufacturing facility.


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