Automation Systems Engineer

4 weeks ago

College Station, Texas, United States CPMNA Full time
Job Summary

CPMNA is seeking an experienced Automation Systems Engineer to join our team. The successful candidate will be responsible for providing technical and operational support, execution of critical projects, installation, operation, maintenance, and troubleshooting of automation systems to meet organizational goals and objectives.

Key Responsibilities
  • Provide support on a daily basis to process control systems, building management systems, and data historian systems.
  • Perform system software updates, security updates, and upgrades to newer versions.
  • Support and enforce the data integrity program.
  • Support and maintenance of computerized systems.
  • Configure and maintain OSI Soft PI Historian and reporting systems.
  • Maintain Functional Specifications, Database Design Specifications, and Hardware Design Specifications for automation systems.
  • Develop and maintain standard operating procedures and trainings for automation systems.
  • Create, support, and maintain customer data sharing programs that include secure customer web portals.
  • Assist in the development and implementation roadmap for the deployment of automation technologies.
  • Execute engineering test plans, factory acceptance tests, and site acceptance tests.
  • Assist in the development of software test specifications, user requirements, and functional specifications.
  • Maintain automation-related systems and configuration backup codes.
  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes.
  • Knowledge of cGMP practices utilized in bulk drug, gene therapy, final formulation filling, and vaccine manufacturing environments.
  • Support computer system validation to ensure that appropriate regulations (e.g., 21 CFR Part 11 and cGMP) are addressed in a development phase and implementation level.
  • Interface with IT to ensure GMP-compliant integration with corporate IT infrastructure.
  • Perform other duties as assigned.
Requirements
  • Bachelor's Degree in Electrical, Mechanical, or Chemical Engineering with one year of experience.
  • Desired experience with critical and non-critical utilities, biotechnology equipment, and complex pharmaceutical systems.
  • At least three years of relevant automation engineering experience in the biotechnology/pharmaceutical industry.
Working Conditions and Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Experience prolonged sitting, standing, bending, stooping, climbing, and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
  • The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Be exposed to noisy environments.
  • Travel time up to 10%.
  • Support company manufacturing activities 24/7.
  • Attendance is mandatory.

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