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Automation Engineer

2 months ago

Raleigh, United States Advanced Recruiting Partners Full time

Position Background:

The Automation Engineer 2 is responsible for supporting any existing and new project automation systems, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, Client, or PI focused, but will be able to support all automation system as required .

Remote Work Designation: Not Remote

Major Accountabilities:

  • Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
  • Support and maintain existing PI data historian in existing manufacturing and R&D facilities
  • In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
  • Support the installation and validation of a DeltaV system for the commercial manufacturing process
  • Support the installation and validation a building automation system for the commercial manufacturing facility
  • Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
  • Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
  • Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
  • Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
  • Perform thorough system tests to ensure robustness of custom automation
  • Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
  • Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
  • Respond to automation-based alarms during standard office hours and as on-call support, as required
  • Support regulatory filings as required
  • Other duties, as assigned

Special Competencies:

  • Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
  • Familiarity with automation of bioprocess applications in GMP facility
  • Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
  • Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
  • Detail-oriented, self-motivated and scientifically driven
  • Strong analytical and problem-solving skills
  • Strong knowledge of GMP quality systems
  • Excellent communication and interpersonal skills


Qualifications:

  • BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
  • At least 3 years of industry experience in process and equipment automation
  • At least 3 years of relevant pharma or biotech industry experience
  • Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
  • Experience installing and/or supporting PI historian system
  • Background in Automation, Electrical Engineering or Mechanical Engineering
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
  • Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines