QA Automation Engineer

2 months ago

College Station, United States BioPharma Consulting JAD Group Full time

Summary: Our Automation team in College Station, Texas is expanding, and we are looking for Automation Engineers to provide technical and operational support, execution of critical projects, installation, operation, maintenance and troubleshooting automation systems to meet organizational goals and objectives. This position will also work closely with other operators, technicians, managers and engineers to maintain complex systems.

Functions:

  • Provide support on a daily basis to process control system, building management systems and data historian systems.
  • Perform system software updates, security updates and upgrades to newer version.
  • Support and enforce the data integrity program.
  • Support and maintenance of computerized systems.
  • OSI Soft PI Historian and reporting system configuration and maintenance.
  • 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 includes but not limited to secure customer web portals.
  • Assist in the development and implementation roadmap for the deployment of automation technologies.
  • Execution of engineering test plans, factory acceptance test and site acceptance test.
  • Assist in the development of software test specification, user requirements and functional specifications.
  • Maintenance of automation related systems and configuration backup codes.
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
  • Knowledge of cGMP practices utilized in bulk drug, gene therapy, final formulation filling and vaccine manufacturing environment.
  • 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.
  • Interfaces with IT to ensure GMP compliant integration with corporate IT infrastructure.
  • Performs other duties as assigned.

Required Skills:

  • Experience with process control, building management, data historian, remote notification and manufacturing enterprise systems.
  • Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, OPC UA and Modbus TCP/IP.
  • Assist in training of automation systems.
  • Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
  • Strong written, verbal and interpersonal communications skills.
  • Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point).

Requirements

Qualifications:

  • Bachelor Degree preferably in Electrical, Mechanical, Chemical Engineering with one (1) year experience.
  • Experience with critical and non-critical utilities, biotechnology equipment and complex pharmaceutical systems are a plus.
  • At least 3 years of relevant automation engineering experience in the biotechnology /pharmaceutical industry.

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