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Process Engineer

1 month ago

College Station, Texas, United States Mentor Technical Group Full time
Job Title: Process Engineer

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 solutions for the FDA-regulated industry.

Key Responsibilities:
  • Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed.
  • Proactively identify engineering problems or opportunities and apply technical expertise to develop and present feasible solutions.
  • Lead and manage new equipment/systems installation including infrastructure, connectivity and capacity assessments.
  • Lead and manage process improvements, corrective and preventive actions (CAPAs) and change controls implementation for process equipment and site utilities.
  • Support new product introductions (NPIs).
  • Work with process sciences in developing new equipment/systems/process design, controls, requirements, specifications and drawings.
  • Liaison with CAPEX team for the implementation of capital projects.
  • Coordinate execution of projects, improvements and other engineering activities.
  • Oversee contractors when implementation and/or corrections are required.
  • Works with QA/QC to 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 in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems.
  • Communicate efficiently with Contractors, Suppliers, OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.
  • Able to work with other contractors, manufacturing, validations and quality control personnel regarding changes or improvements to the systems.
  • 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.
  • Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures.
  • Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications.
  • Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
  • Maintain a positive, professional, and customer-oriented attitude.
Requirements:
  • Bachelor's Degree preferably 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.
Physical Requirements and Working Environment:

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls.

The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell.

The employee may lift and/or move up to 50 pounds and occasionally lift and/or move up to 50 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.

He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

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.